Trial Outcomes & Findings for Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain (NCT NCT03692403)
NCT ID: NCT03692403
Last Updated: 2023-08-18
Results Overview
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes from baseline to cycle 4.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Results posted on
2023-08-18
Participant Flow
The trial was performed in 12 investigational sites in the US between Dec 2018 and Feb 2022
In total, 107 participants were screened. Of these, 85 were screening failures and 22 were randomized. All the randomized participants were exposed to the investigational medical product (IMP): 6 participants to Quinagolide 360 µg, 5 participants to Quinagolide 720 µg, 8 participants to Quinagolide 1080 µg and 3 participants to Placebo.
Participant milestones
| Measure |
Quinagolide 360 µg
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
8
|
3
|
|
Overall Study
COMPLETED
|
5
|
4
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Quinagolide 360 µg
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain
Baseline characteristics by cohort
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=3 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
33.2 years
STANDARD_DEVIATION 9.36 • n=7 Participants
|
37.5 years
STANDARD_DEVIATION 6.65 • n=5 Participants
|
32.0 years
STANDARD_DEVIATION 5.20 • n=4 Participants
|
33.6 years
STANDARD_DEVIATION 7.82 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
3 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
28.33 kg/m^2
STANDARD_DEVIATION 5.428 • n=5 Participants
|
26.58 kg/m^2
STANDARD_DEVIATION 5.006 • n=7 Participants
|
29.91 kg/m^2
STANDARD_DEVIATION 5.038 • n=5 Participants
|
32.33 kg/m^2
STANDARD_DEVIATION 7.190 • n=4 Participants
|
29.05 kg/m^2
STANDARD_DEVIATION 5.348 • n=21 Participants
|
|
Numerical Rating Scale (NRS) at baseline
6
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Numerical Rating Scale (NRS) at baseline
7
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Numerical Rating Scale (NRS) at baseline
8
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Numerical Rating Scale (NRS) at baseline
9
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Numerical Rating Scale (NRS) at baseline
10
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes from baseline to cycle 4.
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=3 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=6 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
|
-0.66 score on a scale
Standard Deviation 1.213
|
-2.04 score on a scale
Standard Deviation 2.092
|
-2.14 score on a scale
Standard Deviation 1.344
|
-3.68 score on a scale
Standard Deviation 1.685
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Days with menstrual bleeding (dysmenorrhea). No menstrual bleeding (non-menstrual pelvic pain) Changes from baseline to cycle 4
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=4 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=6 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding
Non-menstrual pelvic pain
|
-0.69 score on a scale
Standard Deviation 1.236
|
-2.04 score on a scale
Standard Deviation 2.390
|
-2.08 score on a scale
Standard Deviation 1.274
|
-3.37 score on a scale
Standard Deviation 2.040
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain on Days With Menstrual Bleeding and for the Worst Endometriosis-related Pain on Days With no Menstrual Bleeding
Dysmenorrhea
|
-0.51 score on a scale
Standard Deviation 0.989
|
-3.70 score on a scale
Standard Deviation 3.252
|
-2.54 score on a scale
Standard Deviation 1.787
|
-4.90 score on a scale
Standard Deviation 0.495
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=7 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Cycle 2
|
-0.79 score on a scale
Standard Deviation 1.343
|
-2.39 score on a scale
Standard Deviation 3.127
|
-1.63 score on a scale
Standard Deviation 1.254
|
-1.16 score on a scale
Standard Deviation 1.190
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Cycle 4
|
-0.66 score on a scale
Standard Deviation 1.213
|
-2.04 score on a scale
Standard Deviation 2.092
|
-2.14 score on a scale
Standard Deviation 1.344
|
-3.68 score on a scale
Standard Deviation 1.685
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Cycle 1
|
-0.33 score on a scale
Standard Deviation 1.200
|
-1.42 score on a scale
Standard Deviation 0.990
|
-0.51 score on a scale
Standard Deviation 0.733
|
-1.97 score on a scale
Standard Deviation 1.397
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Endometriosis-related Pain.
Cycle 3
|
-0.61 score on a scale
Standard Deviation 1.057
|
-1.71 score on a scale
Standard Deviation 1.788
|
-1.51 score on a scale
Standard Deviation 1.912
|
-2.29 score on a scale
Standard Deviation 2.152
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=7 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea.
Cycle 2
|
-0.95 score on a scale
Standard Deviation 1.678
|
-1.76 score on a scale
Standard Deviation 3.427
|
-1.17 score on a scale
Standard Deviation 1.545
|
-1.15 score on a scale
Standard Deviation 1.556
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea.
Cycle 3
|
0.04 score on a scale
Standard Deviation 1.076
|
-1.00 score on a scale
Standard Deviation 1.442
|
-1.69 score on a scale
Standard Deviation 1.429
|
-3.90 score on a scale
Standard Deviation 0.495
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea.
Cycle 4
|
-0.51 score on a scale
Standard Deviation 0.989
|
-3.70 score on a scale
Standard Deviation 3.252
|
-2.54 score on a scale
Standard Deviation 1.787
|
-4.90 score on a scale
Standard Deviation 0.495
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dysmenorrhea.
Cycle 1
|
-1.10 score on a scale
Standard Deviation 1.051
|
-1.48 score on a scale
Standard Deviation 1.690
|
-0.61 score on a scale
Standard Deviation 0.699
|
-4.40 score on a scale
Standard Deviation 4.455
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain.
Cycle 2
|
-0.69 score on a scale
Standard Deviation 1.484
|
-2.71 score on a scale
Standard Deviation 2.995
|
-1.64 score on a scale
Standard Deviation 1.354
|
-1.22 score on a scale
Standard Deviation 1.036
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain.
Cycle 3
|
-0.77 score on a scale
Standard Deviation 1.194
|
-3.21 score on a scale
Standard Deviation 3.390
|
-1.39 score on a scale
Standard Deviation 2.306
|
-1.88 score on a scale
Standard Deviation 2.632
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain.
Cycle 1
|
-0.09 score on a scale
Standard Deviation 1.457
|
-1.45 score on a scale
Standard Deviation 0.926
|
-0.61 score on a scale
Standard Deviation 0.847
|
-1.42 score on a scale
Standard Deviation 0.693
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Non-menstrual Pelvic Pain.
Cycle 4
|
-0.69 score on a scale
Standard Deviation 1.236
|
-2.04 score on a scale
Standard Deviation 2.390
|
-2.08 score on a scale
Standard Deviation 1.274
|
-3.37 score on a scale
Standard Deviation 2.040
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles.
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=3 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=6 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse.
Cycle 2
|
-1.43 score on a scale
Standard Deviation 2.008
|
-0.06 score on a scale
Standard Deviation 0.756
|
-1.50 score on a scale
Standard Deviation 1.542
|
—
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse.
Cycle 4
|
-1.45 score on a scale
Standard Deviation 1.468
|
0.85 score on a scale
Standard Deviation 1.109
|
-2.03 score on a scale
Standard Deviation 0.864
|
-5.00 score on a scale
Standard Deviation NA
Only 1 participant
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse.
Cycle 1
|
-1.62 score on a scale
Standard Deviation 1.850
|
-0.49 score on a scale
Standard Deviation 1.088
|
-1.69 score on a scale
Standard Deviation 1.972
|
-1.00 score on a scale
Standard Deviation NA
Only 1 participant
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Dyspareunia on Days With Sexual Intercourse.
Cycle 3
|
-0.53 score on a scale
Standard Deviation 1.514
|
-0.29 score on a scale
Standard Deviation 1.551
|
-2.12 score on a scale
Standard Deviation 2.791
|
-7.00 score on a scale
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)The participants recorded daily if they had sexual intercourse, in an e-diary. For the days when participants did not have intercourse, the participant recorded if the reason for not having intercourse was because they expected pain: "Yes" (I did not have intercourse this day, because I expected pain) or "No" (I did not have intercourse this day, but this was not because I expected pain). The numbers represent the cumulative number of days with no intercourse, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=3 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
Cycle 4 - No
|
94 Number of days
|
67 Number of days
|
117 Number of days
|
64 Number of days
|
|
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
Baseline - Yes
|
36 Number of days
|
46 Number of days
|
41 Number of days
|
24 Number of days
|
|
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
Baseline - No
|
103 Number of days
|
94 Number of days
|
154 Number of days
|
48 Number of days
|
|
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
Cycle 1 - Yes
|
38 Number of days
|
20 Number of days
|
35 Number of days
|
22 Number of days
|
|
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
Cycle 1 - No
|
116 Number of days
|
107 Number of days
|
158 Number of days
|
28 Number of days
|
|
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
Cycle 2 - Yes
|
34 Number of days
|
13 Number of days
|
29 Number of days
|
11 Number of days
|
|
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
Cycle 2 - No
|
107 Number of days
|
109 Number of days
|
153 Number of days
|
40 Number of days
|
|
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
Cycle 3 - Yes
|
30 Number of days
|
23 Number of days
|
31 Number of days
|
1 Number of days
|
|
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
Cycle 3 - No
|
112 Number of days
|
106 Number of days
|
122 Number of days
|
51 Number of days
|
|
Frequency of Avoiding Sexual Intercourse Due to Expected Pain
Cycle 4 - Yes
|
29 Number of days
|
11 Number of days
|
28 Number of days
|
3 Number of days
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed daily by participants in an e-Diary. NRS is an 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain. Changes over 4 menstrual cycles.
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=7 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function.
Cycle 1
|
-0.27 score on a scale
Standard Deviation 1.095
|
-1.45 score on a scale
Standard Deviation 1.079
|
-0.31 score on a scale
Standard Deviation 0.741
|
-1.77 score on a scale
Standard Deviation 1.324
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function.
Cycle 2
|
-0.53 score on a scale
Standard Deviation 0.867
|
-2.19 score on a scale
Standard Deviation 3.194
|
-0.95 score on a scale
Standard Deviation 1.281
|
-0.76 score on a scale
Standard Deviation 1.518
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function.
Cycle 3
|
-0.08 score on a scale
Standard Deviation 1.438
|
-1.44 score on a scale
Standard Deviation 1.871
|
-0.87 score on a scale
Standard Deviation 1.847
|
-2.02 score on a scale
Standard Deviation 2.631
|
|
Changes in the Mean Daily Numerical Rating Scale (NRS) Scores for the Worst Impact of Endometriosis-related Pain on the Subject's Ability to Function.
Cycle 4
|
-0.32 score on a scale
Standard Deviation 1.647
|
-1.57 score on a scale
Standard Deviation 2.203
|
-1.48 score on a scale
Standard Deviation 1.649
|
-3.61 score on a scale
Standard Deviation 1.678
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed weekly by participants in an e-Diary. EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement. Changes over 4 menstrual cycles.
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain.
Cycle 4
|
-6.75 score on a scale
Standard Deviation 15.743
|
-24.75 score on a scale
Standard Deviation 35.171
|
-16.01 score on a scale
Standard Deviation 8.624
|
-31.68 score on a scale
Standard Deviation 21.896
|
|
Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain.
Cycle 1
|
-5.54 score on a scale
Standard Deviation 10.939
|
-5.54 score on a scale
Standard Deviation 11.787
|
-7.03 score on a scale
Standard Deviation 10.050
|
-26.66 score on a scale
Standard Deviation 18.146
|
|
Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain.
Cycle 2
|
-5.69 score on a scale
Standard Deviation 16.059
|
-13.53 score on a scale
Standard Deviation 28.807
|
-14.27 score on a scale
Standard Deviation 8.470
|
-4.12 score on a scale
Standard Deviation 17.477
|
|
Changes in the Mean Weekly Scores of the Endometriosis Health Profile-30 (EHP-30) Pain Impact Domain.
Cycle 3
|
-3.19 score on a scale
Standard Deviation 14.065
|
-21.19 score on a scale
Standard Deviation 31.336
|
-13.70 score on a scale
Standard Deviation 12.564
|
-27.89 score on a scale
Standard Deviation 27.253
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded if this was menstrual bleeding: "Yes" (I had a vaginal bleeding that was menstrual bleeding) or "No" (I had a vaginal bleeding that was not menstrual bleeding). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=3 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period
Bleeding related to period - Baseline Yes
|
38 Number of days
|
37 Number of days
|
42 Number of days
|
15 Number of days
|
|
Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period
Bleeding related to period - Baseline No
|
11 Number of days
|
0 Number of days
|
10 Number of days
|
2 Number of days
|
|
Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period
Bleeding related to period - Cycle 4 Yes
|
29 Number of days
|
16 Number of days
|
33 Number of days
|
17 Number of days
|
|
Changes in Vaginal Bleeding Pattern - Number of Days With Bleeding Related to Period
Bleeding related to period - Cycle 4 No
|
3 Number of days
|
5 Number of days
|
2 Number of days
|
0 Number of days
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
The participants recorded daily if they had any vaginal bleeding during the past 24 hours, in an e-diary. Of the participants who had a bleeding, the participant recorded the assessed bleeding volume as either spotting (tiny amount of blood on underwear or panty liners), light bleeding (requiring 1-3 sanitary pads or tampons per day), moderate bleeding (requiring 4-6 sanitary pads or tampons per day), or heavy bleeding (requiring more than 6 sanitary pads or tampons per day). The numbers represent the cumulative number of days with vaginal bleeding, summed across all participants. In some cases, there are missing data as not every participant completed the e-diary for 100% of study days.
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=3 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Vaginal Bleeding Pattern.
No bleeding - Baseline
|
91 Number of days
|
101 Number of days
|
144 Number of days
|
56 Number of days
|
|
Changes in Vaginal Bleeding Pattern.
Light - Baseline
|
17 Number of days
|
11 Number of days
|
12 Number of days
|
8 Number of days
|
|
Changes in Vaginal Bleeding Pattern.
Heavy - Baseline
|
5 Number of days
|
9 Number of days
|
10 Number of days
|
3 Number of days
|
|
Changes in Vaginal Bleeding Pattern.
No Bleeding - Cycle 4
|
91 Number of days
|
57 Number of days
|
110 Number of days
|
50 Number of days
|
|
Changes in Vaginal Bleeding Pattern.
Light - Cycle 4
|
8 Number of days
|
7 Number of days
|
9 Number of days
|
9 Number of days
|
|
Changes in Vaginal Bleeding Pattern.
Heavy - Cycle 4
|
3 Number of days
|
2 Number of days
|
5 Number of days
|
3 Number of days
|
|
Changes in Vaginal Bleeding Pattern.
Spotting - Baseline
|
18 Number of days
|
9 Number of days
|
16 Number of days
|
3 Number of days
|
|
Changes in Vaginal Bleeding Pattern.
Moderate - Baseline
|
10 Number of days
|
11 Number of days
|
15 Number of days
|
3 Number of days
|
|
Changes in Vaginal Bleeding Pattern.
Moderate - Cycle 4
|
9 Number of days
|
4 Number of days
|
10 Number of days
|
3 Number of days
|
|
Changes in Vaginal Bleeding Pattern.
Spotting - Cycle 4
|
12 Number of days
|
8 Number of days
|
11 Number of days
|
2 Number of days
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed daily by participants in an e-Diary
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=7 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Cycle 1 - Any analgesics
|
41.68 percentage of days
Standard Deviation 31.961
|
26.04 percentage of days
Standard Deviation 41.912
|
44.82 percentage of days
Standard Deviation 35.052
|
3.57 percentage of days
Standard Deviation 5.051
|
|
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Cycle 1 - Mild analgesics
|
41.68 percentage of days
Standard Deviation 31.961
|
22.41 percentage of days
Standard Deviation 43.522
|
44.82 percentage of days
Standard Deviation 35.052
|
3.57 percentage of days
Standard Deviation 5.051
|
|
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Cycle 1 - Strong analgesics
|
10.75 percentage of days
Standard Deviation 22.649
|
5.12 percentage of days
Standard Deviation 7.976
|
3.43 percentage of days
Standard Deviation 9.071
|
0 percentage of days
Standard Deviation 0
|
|
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Cycle 2 - Any analgesics
|
40.96 percentage of days
Standard Deviation 37.699
|
25.33 percentage of days
Standard Deviation 42.310
|
36.29 percentage of days
Standard Deviation 39.131
|
20.37 percentage of days
Standard Deviation 28.808
|
|
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Cycle 2 - Mild analgesics
|
40.96 percentage of days
Standard Deviation 37.699
|
21.00 percentage of days
Standard Deviation 44.215
|
36.29 percentage of days
Standard Deviation 39.131
|
20.37 percentage of days
Standard Deviation 28.808
|
|
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Cycle 2 - Strong analgesics
|
12.35 percentage of days
Standard Deviation 30.241
|
10.99 percentage of days
Standard Deviation 14.572
|
2.86 percentage of days
Standard Deviation 7.559
|
0 percentage of days
Standard Deviation 0
|
|
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Cycle 3 - Any analgesics
|
39.67 percentage of days
Standard Deviation 40.008
|
32.25 percentage of days
Standard Deviation 44.036
|
38.62 percentage of days
Standard Deviation 44.213
|
13.46 percentage of days
Standard Deviation 13.598
|
|
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Cycle 3 - Mild analgesics
|
38.00 percentage of days
Standard Deviation 36.920
|
29.47 percentage of days
Standard Deviation 46.115
|
38.62 percentage of days
Standard Deviation 44.213
|
13.46 percentage of days
Standard Deviation 13.598
|
|
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Cycle 3 - Strong analgesics
|
10.83 percentage of days
Standard Deviation 24.224
|
10.13 percentage of days
Standard Deviation 13.880
|
5.17 percentage of days
Standard Deviation 12.670
|
0 percentage of days
Standard Deviation 0
|
|
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Cycle 4 - Any analgesics
|
39.88 percentage of days
Standard Deviation 35.135
|
5.93 percentage of days
Standard Deviation 6.988
|
37.75 percentage of days
Standard Deviation 44.143
|
2.56 percentage of days
Standard Deviation 3.626
|
|
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Cycle 4 - Mild analgesics
|
39.88 percentage of days
Standard Deviation 35.135
|
1.39 percentage of days
Standard Deviation 2.406
|
37.75 percentage of days
Standard Deviation 44.143
|
2.56 percentage of days
Standard Deviation 3.626
|
|
Percentage of Days With Mild and/or Strong Rescue Analgesics Used
Cycle 4 - Strong analgesics
|
9.17 percentage of days
Standard Deviation 20.497
|
4.55 percentage of days
Standard Deviation 7.873
|
3.47 percentage of days
Standard Deviation 8.505
|
0 percentage of days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed daily by participants in an e-Diary
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=7 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Total dose of strong analgesics - Cycle 1
|
1575.8 mg
Standard Deviation 3431.31
|
427.0 mg
Standard Deviation 668.22
|
697.1 mg
Standard Deviation 1844.47
|
0 mg
Standard Deviation 0
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Total dose of mild analgesics - Cycle 1
|
8400.0 mg
Standard Deviation 7740.80
|
5680.0 mg
Standard Deviation 11389.12
|
14514.3 mg
Standard Deviation 14920.17
|
1200.0 mg
Standard Deviation 1697.06
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Average dose of mild analgesics - Cycle 1
|
325.10 mg
Standard Deviation 339.854
|
213.27 mg
Standard Deviation 420.629
|
613.51 mg
Standard Deviation 665.765
|
42.86 mg
Standard Deviation 60.609
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Total dose of mild analgesics - Cycle 2
|
11266.7 mg
Standard Deviation 15184.03
|
5480.0 mg
Standard Deviation 11594.48
|
13485.7 mg
Standard Deviation 17324.30
|
8600.0 mg
Standard Deviation 12162.24
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Average dose of mild analgesics - Cycle 2
|
443.41 mg
Standard Deviation 557.172
|
230.28 mg
Standard Deviation 482.277
|
487.05 mg
Standard Deviation 613.429
|
318.52 mg
Standard Deviation 450.453
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Total dose of mild analgesics - Cycle 3
|
10360.0 mg
Standard Deviation 11802.03
|
10650.0 mg
Standard Deviation 17070.34
|
16166.7 mg
Standard Deviation 17716.17
|
5500.0 mg
Standard Deviation 6646.80
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Average dose of mild analgesics - Cycle 3
|
412.97 mg
Standard Deviation 490.864
|
333.19 mg
Standard Deviation 497.634
|
590.77 mg
Standard Deviation 648.496
|
211.54 mg
Standard Deviation 255.646
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Total dose of mild analgesics - Cycle 4
|
9760.0 mg
Standard Deviation 11939.35
|
400.0 mg
Standard Deviation 692.82
|
15333.3 mg
Standard Deviation 21142.44
|
1200.0 mg
Standard Deviation 1697.06
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Average dose of mild analgesics - Cycle 4
|
403.73 mg
Standard Deviation 507.562
|
16.00 mg
Standard Deviation 27.713
|
606.03 mg
Standard Deviation 824.589
|
30.77 mg
Standard Deviation 43.514
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Average dose of strong analgesics - Cycle 1
|
66.93 mg
Standard Deviation 146.737
|
18.38 mg
Standard Deviation 30.108
|
27.89 mg
Standard Deviation 73.779
|
0 mg
Standard Deviation 0
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Total dose of strong analgesics - Cycle 2
|
2541.7 mg
Standard Deviation 6225.79
|
854.0 mg
Standard Deviation 1086.93
|
915.0 mg
Standard Deviation 2420.86
|
0 mg
Standard Deviation 0
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Average dose of strong analgesics - Cycle 2
|
94.42 mg
Standard Deviation 231.273
|
36.03 mg
Standard Deviation 45.793
|
30.50 mg
Standard Deviation 80.695
|
0 mg
Standard Deviation 0
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Total dose of strong analgesics - Cycle 3
|
2013.0 mg
Standard Deviation 4501.20
|
1143.8 mg
Standard Deviation 1460.08
|
1575.8 mg
Standard Deviation 3859.99
|
0 mg
Standard Deviation 0
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Average dose of strong analgesics - Cycle 3
|
79.38 mg
Standard Deviation 177.493
|
36.55 mg
Standard Deviation 44.327
|
54.34 mg
Standard Deviation 133.103
|
0 mg
Standard Deviation 0
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Total dose of strong analgesics - Cycle 4
|
1159.0 mg
Standard Deviation 2591.60
|
305.0 mg
Standard Deviation 528.28
|
305.0 mg
Standard Deviation 747.09
|
0 mg
Standard Deviation 0
|
|
Total and Average Doses of Mild and/or Strong Rescue Analgesics Used
Average dose of strong analgesics - Cycle 4
|
46.14 mg
Standard Deviation 103.164
|
13.26 mg
Standard Deviation 22.968
|
12.71 mg
Standard Deviation 31.129
|
0 mg
Standard Deviation 0
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed as ≥30%, ≥50% and ≥70% reduction from the baseline in mean daily NRS score for the worst endometriosis-related pain, dysmenorrhea and non-menstrual pelvic pain and for the worst endometriosis-related pain impact
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=4 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=6 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Responder Rate
≥30% reduction - endometriosis-related pain
|
20.0 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Responder Rate
≥30% reduction - dysmenorrhea
|
0 percentage of participants
|
75.0 percentage of participants
|
50.0 percentage of participants
|
100 percentage of participants
|
|
Responder Rate
≥30% reduction - non-menstrual pelvic pain
|
20.0 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Responder Rate
≥30% reduction - impact on the subject's ability to function
|
20.0 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Responder Rate
≥50% reduction - endometriosis-related pain
|
0 percentage of participants
|
25.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Responder Rate
≥50% reduction - dysmenorrhea
|
0 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
100 percentage of participants
|
|
Responder Rate
≥50% reduction - non-menstrual pelvic pain
|
20.0 percentage of participants
|
25.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Responder Rate
≥50% reduction - impact on the subject's ability to function
|
0 percentage of participants
|
50.0 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
|
Responder Rate
≥70% reduction - endometriosis-related pain
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Responder Rate
≥70% reduction - dysmenorrhea
|
0 percentage of participants
|
25.0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Responder Rate
≥70% reduction - non-menstrual pelvic pain
|
0 percentage of participants
|
25.0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Responder Rate
≥70% reduction - impact on the subject's ability to function
|
0 percentage of participants
|
25.0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by the Biberoglu and Behrman (B\&B) scale which is a 4-point scale with 0=none and 3=severe. The scores are the mean individual scores. The B\&B scale consists of two parts. The first part of the B\&B scale evaluates symptoms of endometriosis (i.e. pain). There are 3 subscales: pelvic pain(A, 0=none and 3=severe), dysmenorrhea (B, 0=none and 3=severe), and dyspareunia(C, 0=none and 3=severe). The total pelvic pain score is the sum of the three scores, i.e. A+B+C, which can range from 0 to 9. The second part of the B\&B scale evaluates signs of endometriosis. There are 2 subscales pelvic tenderness (D, 0=none and 3=severe) and induration (E, 0=none and 3=severe) based on findings from a pelvic examination. The total physical pain score is the sum of the two scores, i.e. D+E, which can range from 0 to 6. The total symptom and sign severity score is the sum of all five scores, i.e. A+B+C+D+E, which can range from 0 to 15. The values are the change from baseline to cycle 4.
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in the Mean Individual and Total Symptom and Sign Severity Scores
Total pelvic pain score
|
-1.0 score on a scale
Standard Deviation 1.73
|
-3.0 score on a scale
Standard Deviation 5.66
|
-2.4 score on a scale
Standard Deviation 2.51
|
-5.0 score on a scale
Standard Deviation NA
Only 1 participant
|
|
Changes in the Mean Individual and Total Symptom and Sign Severity Scores
Total physical sign pain score
|
-1.7 score on a scale
Standard Deviation 1.53
|
-1.5 score on a scale
Standard Deviation 0.71
|
-2.2 score on a scale
Standard Deviation 1.48
|
-1.0 score on a scale
Standard Deviation NA
Only 1 participant
|
|
Changes in the Mean Individual and Total Symptom and Sign Severity Scores
Total symptom and sign severity score
|
-2.7 score on a scale
Standard Deviation 3.21
|
-4.5 score on a scale
Standard Deviation 4.95
|
-4.6 score on a scale
Standard Deviation 3.91
|
-6.0 score on a scale
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by the EHP-30 quality-of-life questionnaire completed by participants. Score ranges from 0-100 with lower score denoting improvement.
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores
Cycle 1
|
-7.2 score on a scale
Standard Deviation 15.22
|
-12.8 score on a scale
Standard Deviation 18.09
|
-8.8 score on a scale
Standard Deviation 13.86
|
-39.5 score on a scale
Standard Deviation 74.25
|
|
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores
Cycle 2
|
-2.0 score on a scale
Standard Deviation 22.55
|
-12.0 score on a scale
Standard Deviation 25.88
|
-19.7 score on a scale
Standard Deviation 15.52
|
-49.5 score on a scale
Standard Deviation 68.59
|
|
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores
Cycle 3
|
-2.8 score on a scale
Standard Deviation 20.98
|
-12.4 score on a scale
Standard Deviation 26.02
|
-18.7 score on a scale
Standard Deviation 15.25
|
-14.0 score on a scale
Standard Deviation 11.31
|
|
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores
Cycle 4
|
-4.0 score on a scale
Standard Deviation 33.79
|
-23.3 score on a scale
Standard Deviation 25.63
|
-23.3 score on a scale
Standard Deviation 12.86
|
-50.5 score on a scale
Standard Deviation 31.82
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by the PGIS scale completed by participants. PGIS is a 6-point scale depicting a participant's rating of their current conditions from "good" to "bad". It ranges from 0 (none) to 5 (very severe).
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=4 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=6 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle · No Change
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle · Decreased score
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Endometriosis-related pain during the menstrual bleeding days of the last menstrual cycle · Increased score
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle · No Change
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle · No Change
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle · Decreased score
|
3 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Impact of pain on daily activities during the menstrual bleeding days of the last menstrual cycle · Increased score
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle · No Change
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle · Decreased score
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Impact of pain on daily activities during non-menstrual bleeding days of the last menstrual cycle · Increased score
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Endometriosis-related pain during the last menstrual cycle · No Change
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Endometriosis-related pain during the last menstrual cycle · Decreased score
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Endometriosis-related pain during the last menstrual cycle · Increased score
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle · Decreased score
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Endometriosis-related pain during non-menstrual bleeding days of the last menstrual cycle · Increased score
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Impact of endometriosis-related pain on daily activities during the last menstrual cycle · No Change
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Impact of endometriosis-related pain on daily activities during the last menstrual cycle · Decreased score
|
2 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Changes in Patient Global Impression of Severity (PGIS) Scores
Impact of endometriosis-related pain on daily activities during the last menstrual cycle · Increased score
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by the PGIC scale completed by participants. PGIC is a 7-point scale depicting a patient's rating of their overall improvement from "good" to "bad".
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=4 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=6 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Patient Global Impression of Change (PGIC) Scores
Change in endometriosis-related pain · Very much improved
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in endometriosis-related pain · Much improved
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in endometriosis-related pain · Minimally improved
|
3 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in dysmenorrhea · Very much improved
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in dysmenorrhea · Much improved
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in dysmenorrhea · Minimally improved
|
5 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in dysmenorrhea · No change
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in dysmenorrhea · Very much worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change of non-menstrual pelvic pain · Very much improved
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change of non-menstrual pelvic pain · Minimally improved
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change of non-menstrual pelvic pain · Very much worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in the overall impact of endometriosis-related pain on daily activities · Very much improved
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in the overall impact of endometriosis-related pain on daily activities · No change
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in the overall impact of endometriosis-related pain on daily activities · Very much worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in endometriosis-related pain impact during their menstrual periods · Very much improved
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in endometriosis-related pain impact during their menstrual periods · Much improved
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in endometriosis-related pain impact during their menstrual periods · Minimally improved
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in endometriosis-related pain impact during their menstrual periods · Very much worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in the endometriosis related pain impact during non-menstrual periods · Very much improved
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in the endometriosis related pain impact during non-menstrual periods · Much improved
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in the endometriosis related pain impact during non-menstrual periods · Minimally improved
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in the endometriosis related pain impact during non-menstrual periods · No change
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in endometriosis-related pain · No change
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in endometriosis-related pain · Very much worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change of non-menstrual pelvic pain · Much improved
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change of non-menstrual pelvic pain · No change
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in the overall impact of endometriosis-related pain on daily activities · Much improved
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in the overall impact of endometriosis-related pain on daily activities · Minimally improved
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in endometriosis-related pain impact during their menstrual periods · No change
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Patient Global Impression of Change (PGIC) Scores
Change in the endometriosis related pain impact during non-menstrual periods · Very much worse
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 5 days after first ring insertion and at around 1 month, 3 months, 3.5 months and 4 months after baseline (each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=4 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=7 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Plasma Concentration of Quinagolide and Metabolites
Luteinizing hormone surge + 7 days visit during cycle 1
|
1.84 pg/mL
Standard Deviation 1.31
|
2.36 pg/mL
Standard Deviation 0.750
|
7.10 pg/mL
Standard Deviation 2.36
|
—
|
|
Plasma Concentration of Quinagolide and Metabolites
Return of Menses + 7 days visit during cycle 1
|
1.22 pg/mL
Standard Deviation 0.632
|
1.52 pg/mL
Standard Deviation 0.54
|
3.22 pg/mL
Standard Deviation 1.70
|
—
|
|
Plasma Concentration of Quinagolide and Metabolites
Return of Menses+7 days visit during cycle 4
|
1.47 pg/mL
Standard Deviation 0.799
|
2.07 pg/mL
Standard Deviation 0.85
|
3.41 pg/mL
Standard Deviation 2.43
|
—
|
|
Plasma Concentration of Quinagolide and Metabolites
Within 1-5 days of first ring inserting
|
3.04 pg/mL
Standard Deviation 1.09
|
7.77 pg/mL
Standard Deviation 3.94
|
10.5 pg/mL
Standard Deviation 8.79
|
—
|
|
Plasma Concentration of Quinagolide and Metabolites
Return of Menses+7 days visit during cycle 3
|
1.44 pg/mL
Standard Deviation 0.578
|
2.00 pg/mL
Standard Deviation 0.98
|
5.70 pg/mL
Standard Deviation 5.55
|
—
|
|
Plasma Concentration of Quinagolide and Metabolites
Luteinizing hormone surge + 7 days visit during cycle 4
|
2.08 pg/mL
Standard Deviation 0.65
|
2.92 pg/mL
Standard Deviation NA
Only 1 participant
|
5.13 pg/mL
Standard Deviation 2.91
|
—
|
SECONDARY outcome
Timeframe: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=3 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Serum Levels of Mid-luteal Phase Progesterone
Baseline
|
8.29 ng/mL
Standard Deviation 4.984
|
8.49 ng/mL
Standard Deviation 6.343
|
7.04 ng/mL
Standard Deviation 6.014
|
8.57 ng/mL
Standard Deviation 1.537
|
|
Serum Levels of Mid-luteal Phase Progesterone
Cycle 4
|
9.55 ng/mL
Standard Deviation 7.389
|
6.00 ng/mL
Standard Deviation 6.505
|
6.56 ng/mL
Standard Deviation 6.382
|
0.05 ng/mL
Standard Deviation 0.000
|
SECONDARY outcome
Timeframe: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=3 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml)
Baseline · < 7.9
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml)
Baseline · >= 7.9
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml)
Cycle 4 · < 7.9
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Serum Mid-luteal Progesterone Levels ≥25 Nmol/L (7.9 ng/ml)
Cycle 4 · >= 7.9
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=7 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=3 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Serum Levels of Estradiol
Baseline
|
328.2 pmol/L
Standard Deviation 105.46
|
534.4 pmol/L
Standard Deviation 215.68
|
350.0 pmol/L
Standard Deviation 141.05
|
431.6 pmol/L
Standard Deviation 67.41
|
|
Serum Levels of Estradiol
Cycle 4
|
415.6 pmol/L
Standard Deviation 84.52
|
278.8 pmol/L
Standard Deviation 229.21
|
552.3 pmol/L
Standard Deviation 267.16
|
142.8 pmol/L
Standard Deviation 10.90
|
SECONDARY outcome
Timeframe: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=3 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Serum Levels of Prolactin
Baseline
|
8.0 ng/mL
Standard Deviation 2.40
|
13.2 ng/mL
Standard Deviation 8.25
|
10.0 ng/mL
Standard Deviation 2.95
|
13.4 ng/mL
Standard Deviation 0.69
|
|
Serum Levels of Prolactin
Cycle 4
|
10.7 ng/mL
Standard Deviation 5.04
|
11.3 ng/mL
Standard Deviation 2.97
|
9.0 ng/mL
Standard Deviation 2.50
|
35.7 ng/mL
Standard Deviation 20.22
|
SECONDARY outcome
Timeframe: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=3 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Serum Levels of Thyrotropin (TSH)
Baseline
|
1.9 uIU/mL
Standard Deviation 0.97
|
2.1 uIU/mL
Standard Deviation 1.25
|
1.3 uIU/mL
Standard Deviation 0.56
|
2.7 uIU/mL
Standard Deviation 2.14
|
|
Serum Levels of Thyrotropin (TSH)
Cycle 4
|
1.7 uIU/mL
Standard Deviation 0.55
|
2.1 uIU/mL
Standard Deviation 1.17
|
1.2 uIU/mL
Standard Deviation 0.78
|
2.3 uIU/mL
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and cycle 4 (around 3.5 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=7 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=3 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Serum Levels of Insulin-like Growth Factor-1 (IGF-1)
Baseline
|
216.7 ng/mL
Standard Deviation 50.11
|
221.1 ng/mL
Standard Deviation 89.37
|
166.2 ng/mL
Standard Deviation 59.58
|
188.7 ng/mL
Standard Deviation 12.57
|
|
Serum Levels of Insulin-like Growth Factor-1 (IGF-1)
Cycle 4
|
211.5 ng/mL
Standard Deviation 38.37
|
208.3 ng/mL
Standard Deviation 142.27
|
158.1 ng/mL
Standard Deviation 53.32
|
169.9 ng/mL
Standard Deviation 12.73
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection. Changes from baseline to cycle 4
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Bone Turnover Markers, Determined by Bone Resorption Marker Serum C-terminal Crosslinking Telopeptide of Type 1 Collagen (s-CTx)
|
-0.060 ng/mL
Standard Deviation 0.1210
|
0.277 ng/mL
Standard Deviation 0.3026
|
0.067 ng/mL
Standard Deviation 0.0685
|
-0.031 ng/mL
Standard Deviation 0.0354
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection. Changes from baseline to cycle 4
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=4 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Bone Turnover Markers, Determined by Bone Formation Marker Serum Procollagen Type I N Propeptide (s-PINP)
|
-1.4 ng/mL
Standard Deviation 9.56
|
-3.5 ng/mL
Standard Deviation 6.36
|
10.3 ng/mL
Standard Deviation 20.12
|
-21.0 ng/mL
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by 12-lead ECG
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=4 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in ECG Parameters Including PR Interval at Cycle 4
|
-1.8 msec
Standard Deviation 11.17
|
8.0 msec
Standard Deviation 8.72
|
1.0 msec
Standard Deviation 11.66
|
-2.5 msec
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by 12-lead ECG
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=4 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in ECG Parameters Including QRS Duration at Cycle 4
|
-0.2 msec
Standard Deviation 4.82
|
5.0 msec
Standard Deviation 5.83
|
2.8 msec
Standard Deviation 7.19
|
-7.5 msec
Standard Deviation 9.19
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by 12-lead ECG
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=4 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in ECG Parameters Including QT Interval at Cycle 4
|
-1.2 msec
Standard Deviation 22.33
|
-7.5 msec
Standard Deviation 23.61
|
18.0 msec
Standard Deviation 30.32
|
7.0 msec
Standard Deviation 5.66
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by 12-lead ECG
Outcome measures
| Measure |
Quinagolide 360 µg
n=5 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=4 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in ECG Parameters Including QTcF Interval at Cycle 4
|
-6.2 msec
Standard Deviation 6.18
|
1.5 msec
Standard Deviation 11.39
|
3.2 msec
Standard Deviation 13.22
|
-17.5 msec
Standard Deviation 33.23
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by echocardiography. Each echocardiography was to be assessed as normal or abnormal according to American College of Cardiology/American Heart Association guidelines for valvular heart disease. If abnormal, the level of valvular regurgitation and valvular stenosis was specified as mild, moderate or severe and valvular structure was evaluated as well. Measured at cycle 4.
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=3 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Proportion of Subjects With Abnormal Clinically Significant Echocardiography Findings Indicating Valvular Heart Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by the questionnaire for impulsive-compulsive disorders completed by participants. Measured at cycle 4.
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Proportion of Subjects Identified With Potential Impulse Control Disorders
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From signing informed consent through study completion, around 8 monthsAssessed by an Adverse Events Log completed by the Investigator
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=8 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=3 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Frequency and Intensity of Adverse Events
Treatment emergent adverse events
|
4 participants
|
3 participants
|
5 participants
|
2 participants
|
|
Frequency and Intensity of Adverse Events
Mild adverse events
|
4 participants
|
2 participants
|
4 participants
|
2 participants
|
|
Frequency and Intensity of Adverse Events
Moderate adverse events
|
2 participants
|
2 participants
|
2 participants
|
2 participants
|
|
Frequency and Intensity of Adverse Events
Severe adverse events
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Albumin
|
-0.5 g/L
Standard Deviation 3.00
|
0.5 g/L
Standard Deviation 2.12
|
-2.8 g/L
Standard Deviation 2.28
|
-3.0 g/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Alkaline Phosphatase
|
-16.5 IU/L
Standard Deviation 20.94
|
26.5 IU/L
Standard Deviation 45.96
|
-7.2 IU/L
Standard Deviation 14.62
|
-13.0 IU/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Alanine Aminotransferase
|
-8.3 IU/L
Standard Deviation 23.26
|
46.0 IU/L
Standard Deviation 69.30
|
-5.8 IU/L
Standard Deviation 6.38
|
-3.0 IU/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Aspartate Aminotransferase
|
-5.3 IU/L
Standard Deviation 14.57
|
26.5 IU/L
Standard Deviation 41.72
|
-0.6 IU/L
Standard Deviation 1.14
|
4.0 IU/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Bicarbonate
|
-0.8 mmol/L
Standard Deviation 2.63
|
0.5 mmol/L
Standard Deviation 3.54
|
-0.2 mmol/L
Standard Deviation 1.92
|
-2.0 mmol/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Direct Bilirubin
|
0.0 umol/L
Standard Deviation 0.0
|
0.0 umol/L
Standard Deviation 0.0
|
-0.7 umol/L
Standard Deviation 0.72
|
0.0 umol/L
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Bilirubin
|
1.3 umol/L
Standard Deviation 2.57
|
4.3 umol/L
Standard Deviation 3.63
|
-2.1 umol/L
Standard Deviation 2.23
|
1.7 umol/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Calcium
|
0.0 mmol/L
Standard Deviation 0.06
|
0.0 mmol/L
Standard Deviation 0.05
|
-0.1 mmol/L
Standard Deviation 0.07
|
-0.1 mmol/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Cholesterol
|
0.7 mmol/L
Standard Deviation 0.46
|
0.5 mmol/L
Standard Deviation 0.49
|
0.1 mmol/L
Standard Deviation 0.27
|
-0.1 mmol/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Chloride
|
0.8 mmol/L
Standard Deviation 1.71
|
1.0 mmol/L
Standard Deviation 0.00
|
1.4 mmol/L
Standard Deviation 2.51
|
2.5 mmol/L
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Creatinine
|
-3.3 umol/L
Standard Deviation 13.39
|
-10.6 umol/L
Standard Deviation 3.75
|
0.0 umol/L
Standard Deviation 7.26
|
0.9 umol/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Gamma Glutamyl Transferase
|
-3.5 IU/L
Standard Deviation 9.75
|
11.0 IU/L
Standard Deviation 14.14
|
-2.8 IU/L
Standard Deviation 11.32
|
-9.0 IU/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Glucose
|
-0.3 mmol/L
Standard Deviation 0.40
|
-0.6 mmol/L
Standard Deviation 0.59
|
-0.1 mmol/L
Standard Deviation 0.49
|
4.8 mmol/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Potassium
|
-0.2 mmol/L
Standard Deviation 0.58
|
-0.1 mmol/L
Standard Deviation 0.00
|
-0.3 mmol/L
Standard Deviation 0.32
|
-0.5 mmol/L
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Lactate Dehydrogenase
|
-11.8 IU/L
Standard Deviation 14.86
|
35.0 IU/L
Standard Deviation 55.15
|
-16.0 IU/L
Standard Deviation 14.68
|
8.0 IU/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Phosphate
|
0.1 mmol/L
Standard Deviation 0.08
|
-0.1 mmol/L
Standard Deviation 0.43
|
0.0 mmol/L
Standard Deviation 0.12
|
0.0 mmol/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Protein
|
-0.8 g/L
Standard Deviation 4.35
|
0.0 g/L
Standard Deviation 2.83
|
-3.4 g/L
Standard Deviation 3.65
|
-5.0 g/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Sodium
|
1.5 mmol/L
Standard Deviation 1.73
|
-1.5 mmol/L
Standard Deviation 3.54
|
1.2 mmol/L
Standard Deviation 2.39
|
0.5 mmol/L
Standard Deviation 4.95
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Urate
|
-5.9 umol/L
Standard Deviation 31.85
|
-23.8 umol/L
Standard Deviation 50.47
|
10.7 umol/L
Standard Deviation 64.80
|
41.6 umol/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Chemistry Parameters: Urea Nitrogen
|
0.3 mmol/L
Standard Deviation 2.21
|
-2.0 mmol/L
Standard Deviation 0.76
|
-0.4 mmol/L
Standard Deviation 0.84
|
-0.7 mmol/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Basophils Absolute
|
-0.3 Basophils Absolute (%)
Standard Deviation 0.25
|
-0.4 Basophils Absolute (%)
Standard Deviation 0.21
|
0.0 Basophils Absolute (%)
Standard Deviation 0.05
|
0.1 Basophils Absolute (%)
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Basophils
|
0.0 *10^3 cells/uL
Standard Deviation 0.03
|
0.0 *10^3 cells/uL
Standard Deviation 0.02
|
0.0 *10^3 cells/uL
Standard Deviation 0.02
|
0.0 *10^3 cells/uL
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils Absolute
|
-0.6 Eosinophils Absolute (%)
Standard Deviation 0.71
|
-0.3 Eosinophils Absolute (%)
Standard Deviation 2.19
|
-1.4 Eosinophils Absolute (%)
Standard Deviation 3.73
|
0.0 Eosinophils Absolute (%)
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Eosinophils
|
-0.1 *10^3 cells/uL
Standard Deviation 0.02
|
-0.1 *10^3 cells/uL
Standard Deviation 0.14
|
0.0 *10^3 cells/uL
Standard Deviation 0.13
|
0.0 *10^3 cells/uL
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Hematocrit
|
0.0 RATIO
Standard Deviation 0.03
|
0.0 RATIO
Standard Deviation 0.02
|
0.0 RATIO
Standard Deviation 0.03
|
0.0 RATIO
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Hemoglobin
|
1.3 g/L
Standard Deviation 10.07
|
-1.5 g/L
Standard Deviation 14.85
|
-6.0 g/L
Standard Deviation 7.87
|
0.0 g/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes Absolute
|
2.5 Lymphocytes Absolute (%)
Standard Deviation 1.96
|
-0.6 Lymphocytes Absolute (%)
Standard Deviation 0.35
|
-2.1 Lymphocytes Absolute (%)
Standard Deviation 8.22
|
3.9 Lymphocytes Absolute (%)
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Lymphocytes
|
0.3 *10^3 cells/uL
Standard Deviation 0.39
|
-0.2 *10^3 cells/uL
Standard Deviation 0.54
|
-0.1 *10^3 cells/uL
Standard Deviation 0.43
|
0.3 *10^3 cells/uL
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Hemoglobin
|
0.3 pg/cell
Standard Deviation 0.58
|
0.0 pg/cell
Standard Deviation 0.0
|
-0.2 pg/cell
Standard Deviation 0.45
|
0.0 pg/cell
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular HGB Concentration
|
0.2 mmol/L
Standard Deviation 0.72
|
0.3 mmol/L
Standard Deviation 1.32
|
-0.1 mmol/L
Standard Deviation 0.52
|
1.2 mmol/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Ery. Mean Corpuscular Volume
|
0.0 fL
Standard Deviation 2.65
|
0.5 fL
Standard Deviation 3.54
|
0.2 fL
Standard Deviation 1.64
|
-3.0 fL
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes Absolute
|
-2.1 Monocytes Absolute (%)
Standard Deviation 0.26
|
-2.2 Monocytes Absolute (%)
Standard Deviation 1.34
|
-0.1 Monocytes Absolute (%)
Standard Deviation 1.32
|
0.6 Monocytes Absolute (%)
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Monocytes
|
-0.2 *10^3 cells/uL
Standard Deviation 0.03
|
-0.2 *10^3 cells/uL
Standard Deviation 0.04
|
0.0 *10^3 cells/uL
Standard Deviation 0.13
|
0.0 *10^3 cells/uL
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils Absolute
|
0.6 Neutrophils Absolute (%)
Standard Deviation 2.74
|
3.4 Neutrophils Absolute (%)
Standard Deviation 2.90
|
3.7 Neutrophils Absolute (%)
Standard Deviation 7.28
|
-4.6 Neutrophils Absolute (%)
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Neutrophils
|
0.3 *10^3 cells/uL
Standard Deviation 1.37
|
0.0 *10^3 cells/uL
Standard Deviation 1.67
|
0.1 *10^3 cells/uL
Standard Deviation 1.52
|
-0.3 *10^3 cells/uL
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Platelets
|
-10.3 10^9 cells/L
Standard Deviation 26.54
|
36.5 10^9 cells/L
Standard Deviation 50.20
|
1.8 10^9 cells/L
Standard Deviation 33.33
|
12.0 10^9 cells/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Erythrocytes
|
-0.1 10^12 cells/L
Standard Deviation 0.35
|
-0.1 10^12 cells/L
Standard Deviation 0.42
|
-0.2 10^12 cells/L
Standard Deviation 0.24
|
-0.1 10^12 cells/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=3 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Changes in Circulating Levels of Clinical Haematology Parameters: Leukocytes
|
0.3 10^9 cells/L
Standard Deviation 1.72
|
-0.5 10^9 cells/L
Standard Deviation 2.05
|
0.0 10^9 cells/L
Standard Deviation 1.63
|
0.0 10^9 cells/L
Standard Deviation NA
Only 1 participant
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by urine sample collection (dip-stick test). Overall Urinalysis Result.
Outcome measures
| Measure |
Quinagolide 360 µg
n=1 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=1 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=2 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity)
Normal overall urinalysis result
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Urinalysis Parameters (Protein, Glucose, Bilirubin, pH, Nitrite, Ketone, Urobilinogen, Blood, Leukocytes, and Specific Gravity)
Abnormal overall urinalysis result
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Chemistry Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by blood samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=4 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=2 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=5 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=1 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Proportion of Subjects With Markedly Abnormal Changes in Circulating Levels of Clinical Haematology Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by urine samples collection
Outcome measures
| Measure |
Quinagolide 360 µg
n=1 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=1 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=2 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Proportion of Subjects With Markedly Abnormal Changes in Urinalysis Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by a questionnaire completed by participants, addressing ring insertion
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=7 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 1 · Easy
|
2 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 1 · Easier than the previous ring
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 1 · Difficult
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 1 · Not Applicable (I was not given a new ring)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 2 · Easy
|
5 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 2 · Not Applicable (I was not given a new ring)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 3 · Difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 3 · Not Applicable (I was not given a new ring)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 4 · Easy
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 4 · Easier than the previous ring
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 4 · Difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 4 · Not Applicable (I was not given a new ring)
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 2 · Easier than the previous ring
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 2 · Difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 3 · Easy
|
3 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Insertion of the Vaginal Ring
Cycle 3 · Easier than the previous ring
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by a questionnaire completed by participants, addressing ring removal.
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=7 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring
Cycle 1 · Easy
|
6 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring
Cycle 1 · Difficult
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring
Cycle 2 · Easy
|
6 Participants
|
5 Participants
|
7 Participants
|
1 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring
Cycle 3 · Easy
|
4 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring
Cycle 3 · Difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring
Cycle 4 · Easy
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring
Cycle 4 · Difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Removal of the Vaginal Ring
Cycle 2 · Difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From baseline to menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)Population: Participants analyzed for this endpoint represent participants who were evaluable for this outcome measure.
Assessed by a questionnaire completed by participants, addressing any feeling of the ring while the ring is in the body.
Outcome measures
| Measure |
Quinagolide 360 µg
n=6 Participants
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
|
Quinagolide 720 µg
n=5 Participants
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases
|
Quinagolide 1080 µg
n=7 Participants
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases
|
Placebo
n=2 Participants
Vaginal ring containing matching placebo
Placebo: Matching placebo
|
|---|---|---|---|---|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 1 · Occasionally
|
6 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 1 · Always
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 2 · Never
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 2 · Occasionally
|
5 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 2 · Frequently
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 2 · Always
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 3 · Never
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 3 · Occasionally
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 3 · Frequently
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 3 · Always
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 4 · Never
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 4 · Occasionally
|
2 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 4 · Frequently
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 4 · Always
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 1 · Never
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Frequency and Intensity of Ring Acceptability Parameters: Felt the Ring
Cycle 1 · Frequently
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Quinagolide 360 µg - Part A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Quinagolide 720 µg - Part A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Quinagolide 1080 µg - Part A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo - Part A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Quinagolide 360 µg - Part B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Quinagolide 720 µg - Part B
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Quinagolide 1080 µg - Part B
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quinagolide 360 µg - Part A
n=6 participants at risk
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
Part A is cycle 1-4.
|
Quinagolide 720 µg - Part A
n=5 participants at risk
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases.
Part A is cycle 1-4.
|
Quinagolide 1080 µg - Part A
n=8 participants at risk
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases.
Part A is cycle 1-4.
|
Placebo - Part A
n=3 participants at risk
Vaginal ring containing matching placebo
Placebo: Matching placebo.
Only Part A. No participants were exposed to placebo vaginal ring during Part B of the trial.
|
Quinagolide 360 µg - Part B
n=3 participants at risk
Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg
Quinagolide 360 µg: Vaginal ring containing quinagolide 360 µg for daily releases
Part B is cycle 5-8.
|
Quinagolide 720 µg - Part B
n=3 participants at risk
Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg
Quinagolide 720 µg: Vaginal ring containing quinagolide 720 µg for daily releases.
Part B is cycle 5-8.
2 participants received Quinagolide 720 µg for both Part A and Part B (8 cycles total) and 1 participant received placebo for Part A (4 cycles) and Quinagolide 720 µg for Part B (4 cycles).
|
Quinagolide 1080 µg - Part B
n=7 participants at risk
Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg
Quinagolide 1080 µg: Vaginal ring containing quinagolide 1080 µg for daily releases.
Part B is cycle 5-8.
6 participants received Quinagolide 1080 µg for both Part A and Part B (8 cycles total) and 1 participant received placebo for Part A (4 cycles) and Quinagolide 1080 µg for Part B (4 cycles).
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 2 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
25.0%
2/8 • Number of events 2 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
14.3%
1/7 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Conjunctivitis
|
16.7%
1/6 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
12.5%
1/8 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Injury, poisoning and procedural complications
Exposure during pregnancy
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
12.5%
1/8 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Reproductive system and breast disorders
Genital burning sensation
|
16.7%
1/6 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
16.7%
1/6 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
16.7%
1/6 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
12.5%
1/8 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
16.7%
1/6 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
16.7%
1/6 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
16.7%
1/6 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
20.0%
1/5 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
14.3%
1/7 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Mastitis bacterial
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Pharyngitis bacterial
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
14.3%
1/7 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
14.3%
1/7 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical granuloma
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
14.3%
1/7 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Psychiatric disorders
obsessive-compulsive symptom
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
14.3%
1/7 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Reproductive system and breast disorders
Bacterial vaginosis
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
14.3%
1/7 • Number of events 2 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
|
Reproductive system and breast disorders
Uterine disorder
|
0.00%
0/6 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/5 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/8 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/3 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
33.3%
1/3 • Number of events 1 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
0.00%
0/7 • Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months).
Adverse events were recorded from signing of the informed consent until end-of-trial (around 8 months). All AEs occurring after start of first administration of IMP and before the follow-up visit were considered treatment-emergent.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER