Trial Outcomes & Findings for A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids (NCT NCT02301897)
NCT ID: NCT02301897
Last Updated: 2019-06-19
Results Overview
Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
At the end of 18-weeks Treatment Course 1
Results posted on
2019-06-19
Participant Flow
Participant milestones
| Measure |
Telapristone Acetate 6 mg
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Treatment Course 1
STARTED
|
12
|
17
|
14
|
|
Treatment Course 1
COMPLETED
|
9
|
14
|
8
|
|
Treatment Course 1
NOT COMPLETED
|
3
|
3
|
6
|
|
Treatment Course 2
STARTED
|
9
|
14
|
8
|
|
Treatment Course 2
COMPLETED
|
8
|
9
|
7
|
|
Treatment Course 2
NOT COMPLETED
|
1
|
5
|
1
|
Reasons for withdrawal
| Measure |
Telapristone Acetate 6 mg
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Treatment Course 1
Non-Compliance
|
0
|
0
|
1
|
|
Treatment Course 1
Adverse Event
|
1
|
1
|
0
|
|
Treatment Course 1
Lost to Follow-up
|
1
|
2
|
1
|
|
Treatment Course 1
Withdrawal by Sponsor
|
0
|
0
|
2
|
|
Treatment Course 1
Withdrawal by Subject
|
0
|
0
|
2
|
|
Treatment Course 1
Other Miscellaneous Reasons
|
1
|
0
|
0
|
|
Treatment Course 2
Lost to Follow-up
|
0
|
2
|
0
|
|
Treatment Course 2
Pregnancy
|
0
|
1
|
1
|
|
Treatment Course 2
Withdrawal by Subject
|
0
|
2
|
0
|
|
Treatment Course 2
Other Miscellaneous Reasons
|
1
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.8 years
n=12 Participants
|
41.4 years
n=17 Participants
|
41.9 years
n=14 Participants
|
41.4 years
n=43 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=12 Participants
|
17 Participants
n=17 Participants
|
14 Participants
n=14 Participants
|
43 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=12 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=43 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: At the end of 18-weeks Treatment Course 1Population: Intent-to-treat (ITT) population consisted of all participants who were randomized and received study drug.
Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage of Participants in Amenorrhea at the End of Treatment Course 1
|
58.33 percentage of participants
|
70.59 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: At the end of 18-weeks Treatment Course 2Population: ITT population consisted of all participants who were randomized and received study drug.
Amenorrhea was defined as no bleeding intensity score greater than 1 using the Daily Diary Card during the 28 days leading up to the last day of dosing at Week 18. Bleeding intensity was graded on a 5-point scale where: 0=no bleeding to 4=heavy bleeding.
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage of Participants in Amenorrhea at the End of Treatment Course 2
|
25.00 percentage of participants
|
64.71 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU VisitPopulation: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding) to \>500. Higher scores indicate more bleeding. Lower scores indicate less bleeding. A negative change from Baseline indicates improvement (reduction in bleeding).
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit
Baseline
|
316.82 score on a scale
Standard Deviation 162.828
|
371.20 score on a scale
Standard Deviation 332.028
|
267.07 score on a scale
Standard Deviation 119.334
|
|
Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit
Change from Baseline (CFB) to Week 18 Course 1
|
-340.61 score on a scale
Standard Deviation 151.198
|
-364.55 score on a scale
Standard Deviation 342.572
|
-44.48 score on a scale
Standard Deviation 468.771
|
|
Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit
CFB to ODI Course 1
|
-100.92 score on a scale
Standard Deviation 238.412
|
-127.41 score on a scale
Standard Deviation 282.914
|
-104.92 score on a scale
Standard Deviation 261.137
|
|
Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit
CFB to Week 18 Course 2
|
-323.20 score on a scale
Standard Deviation 138.553
|
-396.69 score on a scale
Standard Deviation 367.242
|
-238.86 score on a scale
Standard Deviation 164.498
|
|
Change in Pictorial Blood Loss Assessment Chart (PBAC) Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 Follow-up (FU) Visit
CFB to Course 2 Week 28 FU
|
-220.50 score on a scale
Standard Deviation 137.805
|
-655.33 score on a scale
Standard Deviation 466.031
|
-324.70 score on a scale
Standard Deviation 109.884
|
SECONDARY outcome
Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, the end of ODI Course 1, the end of 18-weeks Treatment Course 2 and the Course 2 Week 28 FU VisitPopulation: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Participants recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Pictorial scores range from score 1 for slightly stained tampon/towel, 5 for a partially stained tampon/towel, 10 for a completely saturated tampon, 20 for a completely saturated towel, and 5 for each episode of flooding and for each blood clot larger than a quarter in size. Total score can range from 0 (no bleeding) to \>500. Higher scores indicate more bleeding. Lower scores indicate less bleeding. A negative percentage change from Baseline indicates improvement (reduction in bleeding).
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit
Percentage CFB to Week 18 Course 1
|
-96.95 percentage change in PBAC score
Standard Deviation 7.952
|
-94.58 percentage change in PBAC score
Standard Deviation 16.256
|
59.70 percentage change in PBAC score
Standard Deviation 357.363
|
|
Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit
Percentage CFB to ODI Course 1
|
33.22 percentage change in PBAC score
Standard Deviation 236.393
|
1.41 percentage change in PBAC score
Standard Deviation 85.953
|
6.69 percentage change in PBAC score
Standard Deviation 165.599
|
|
Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit
Percentage CFB to Week 18 Course 2
|
-98.69 percentage change in PBAC score
Standard Deviation 3.448
|
-100.00 percentage change in PBAC score
Standard Deviation 0.000
|
-75.00 percentage change in PBAC score
Standard Deviation 29.476
|
|
Percentage Change in PBAC Score From Baseline to the End of Treatment Courses 1 and 2, ODI Course 1 and the Course 2 Week 28 FU Visit
Percentage CFB to Course 2 Week 28 FU
|
-55.48 percentage change in PBAC score
Standard Deviation 27.739
|
-81.59 percentage change in PBAC score
Standard Deviation 20.066
|
-99.68 percentage change in PBAC score
Standard Deviation 0.454
|
SECONDARY outcome
Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU VisitPopulation: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. Each question was answered on a 5-point scale where 1=Not at all to 5=A very great deal. The sum of total scores was transformed to a range of 0=no symptoms (best) to 100=most severe symptoms (worst). A negative percentage change from Baseline indicates improvement.
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 1
|
-70.41 percentage change in UFS-SSS score
Standard Deviation 14.656
|
-68.46 percentage change in UFS-SSS score
Standard Deviation 31.874
|
-32.99 percentage change in UFS-SSS score
Standard Deviation 25.658
|
|
Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to On-Drug Course 2
|
-58.36 percentage change in UFS-SSS score
Standard Deviation 31.193
|
-75.40 percentage change in UFS-SSS score
Standard Deviation 28.158
|
-44.62 percentage change in UFS-SSS score
Standard Deviation 39.429
|
|
Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 2
|
-69.17 percentage change in UFS-SSS score
Standard Deviation 24.150
|
-80.23 percentage change in UFS-SSS score
Standard Deviation 29.252
|
-56.65 percentage change in UFS-SSS score
Standard Deviation 38.700
|
|
Percentage Change in Uterine Fibroid System Quality of Life Survey System Severity (UFS-SSS) Score From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Course 2 Week 24 FU
|
-33.85 percentage change in UFS-SSS score
Standard Deviation 50.603
|
-40.45 percentage change in UFS-SSS score
Standard Deviation 42.753
|
-60.53 percentage change in UFS-SSS score
Standard Deviation 36.144
|
SECONDARY outcome
Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU VisitPopulation: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 1: During the previous 3 months how distressed were you by "heavy bleeding during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 1
|
-87.50 percentage change in UFS-SSS score
Standard Deviation 27.003
|
-83.33 percentage change in UFS-SSS score
Standard Deviation 34.932
|
-40.91 percentage change in UFS-SSS score
Standard Deviation 39.167
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to On-Drug Course 2
|
-69.44 percentage change in UFS-SSS score
Standard Deviation 37.034
|
-95.83 percentage change in UFS-SSS score
Standard Deviation 14.434
|
-44.79 percentage change in UFS-SSS score
Standard Deviation 31.477
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 2
|
-86.11 percentage change in UFS-SSS score
Standard Deviation 28.260
|
-95.45 percentage change in UFS-SSS score
Standard Deviation 15.076
|
-57.14 percentage change in UFS-SSS score
Standard Deviation 37.401
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 1 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Course 2 Week 24 FU
|
-39.29 percentage change in UFS-SSS score
Standard Deviation 31.810
|
-25.00 percentage change in UFS-SSS score
Standard Deviation 30.046
|
-72.92 percentage change in UFS-SSS score
Standard Deviation 35.600
|
SECONDARY outcome
Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU VisitPopulation: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 2: During the previous 3 months how distressed were you by "passing blood clots during your menstrual period"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 1
|
-95.00 percentage change in UFS-SSS score
Standard Deviation 15.811
|
-79.44 percentage change in UFS-SSS score
Standard Deviation 41.888
|
-40.91 percentage change in UFS-SSS score
Standard Deviation 62.965
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to On-Drug Course 2
|
-66.67 percentage change in UFS-SSS score
Standard Deviation 41.458
|
-89.58 percentage change in UFS-SSS score
Standard Deviation 29.113
|
-38.54 percentage change in UFS-SSS score
Standard Deviation 45.630
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 2
|
-80.56 percentage change in UFS-SSS score
Standard Deviation 34.861
|
-88.64 percentage change in UFS-SSS score
Standard Deviation 30.339
|
-53.57 percentage change in UFS-SSS score
Standard Deviation 50.428
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 2 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Course 2 Week 24 FU
|
-54.76 percentage change in UFS-SSS score
Standard Deviation 39.044
|
-37.96 percentage change in UFS-SSS score
Standard Deviation 43.123
|
-64.58 percentage change in UFS-SSS score
Standard Deviation 41.037
|
SECONDARY outcome
Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU VisitPopulation: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 3: During the previous 3 months how distressed were you by "fluctuation in the duration of your menstrual period compared to your previous cycle"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 1
|
-65.63 percentage change in UFS-SSS score
Standard Deviation 69.356
|
-78.57 percentage change in UFS-SSS score
Standard Deviation 45.844
|
-37.88 percentage change in UFS-SSS score
Standard Deviation 35.622
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to On-Drug Course 2
|
-18.75 percentage change in UFS-SSS score
Standard Deviation 134.131
|
-56.25 percentage change in UFS-SSS score
Standard Deviation 98.929
|
-32.29 percentage change in UFS-SSS score
Standard Deviation 57.466
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 2
|
-84.38 percentage change in UFS-SSS score
Standard Deviation 26.517
|
-79.55 percentage change in UFS-SSS score
Standard Deviation 60.019
|
-55.95 percentage change in UFS-SSS score
Standard Deviation 46.327
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 3 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Course 2 Week 24 FU
|
-30.56 percentage change in UFS-SSS score
Standard Deviation 73.156
|
-18.52 percentage change in UFS-SSS score
Standard Deviation 103.898
|
-25.00 percentage change in UFS-SSS score
Standard Deviation 95.743
|
SECONDARY outcome
Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU VisitPopulation: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 4: During the previous 3 months how distressed were you by "fluctuation in the length of your monthly cycle compared to your previous cycles"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 1
|
-35.71 percentage change in UFS-SSS score
Standard Deviation 149.204
|
-64.29 percentage change in UFS-SSS score
Standard Deviation 65.570
|
-15.83 percentage change in UFS-SSS score
Standard Deviation 56.988
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to On-Drug Course 2
|
-14.29 percentage change in UFS-SSS score
Standard Deviation 141.316
|
-52.27 percentage change in UFS-SSS score
Standard Deviation 102.746
|
7.14 percentage change in UFS-SSS score
Standard Deviation 103.574
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 2
|
-82.14 percentage change in UFS-SSS score
Standard Deviation 27.817
|
-77.50 percentage change in UFS-SSS score
Standard Deviation 62.860
|
-38.89 percentage change in UFS-SSS score
Standard Deviation 57.413
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 4 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Course 2 Week 24 FU
|
-51.67 percentage change in UFS-SSS score
Standard Deviation 38.370
|
-45.83 percentage change in UFS-SSS score
Standard Deviation 68.284
|
0.00 percentage change in UFS-SSS score
Standard Deviation 100.000
|
SECONDARY outcome
Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU VisitPopulation: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 5: During the previous 3 months how distressed were you by "feeling tightness or pressure in your pelvic area"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 1
|
-72.50 percentage change in UFS-SSS score
Standard Deviation 24.861
|
-76.19 percentage change in UFS-SSS score
Standard Deviation 33.310
|
-37.50 percentage change in UFS-SSS score
Standard Deviation 48.631
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to On-Drug Course 2
|
-74.07 percentage change in UFS-SSS score
Standard Deviation 25.154
|
-86.36 percentage change in UFS-SSS score
Standard Deviation 30.339
|
-56.25 percentage change in UFS-SSS score
Standard Deviation 42.667
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 2
|
-82.41 percentage change in UFS-SSS score
Standard Deviation 28.396
|
-86.36 percentage change in UFS-SSS score
Standard Deviation 30.339
|
-64.29 percentage change in UFS-SSS score
Standard Deviation 39.002
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 5 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Course 2 Week 24 FU
|
-35.71 percentage change in UFS-SSS score
Standard Deviation 73.396
|
-29.63 percentage change in UFS-SSS score
Standard Deviation 41.481
|
-58.33 percentage change in UFS-SSS score
Standard Deviation 50.000
|
SECONDARY outcome
Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU VisitPopulation: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 6: During the previous 3 months how distressed were you by "frequent urination during the daytime hours"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 1
|
-38.33 percentage change in UFS-SSS score
Standard Deviation 39.323
|
-46.11 percentage change in UFS-SSS score
Standard Deviation 54.724
|
-2.50 percentage change in UFS-SSS score
Standard Deviation 78.572
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to On-Drug Course 2
|
-38.89 percentage change in UFS-SSS score
Standard Deviation 48.591
|
-58.33 percentage change in UFS-SSS score
Standard Deviation 63.365
|
-61.90 percentage change in UFS-SSS score
Standard Deviation 37.223
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 2
|
-49.07 percentage change in UFS-SSS score
Standard Deviation 47.952
|
-54.55 percentage change in UFS-SSS score
Standard Deviation 65.017
|
-34.72 percentage change in UFS-SSS score
Standard Deviation 73.865
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 6 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Course 2 Week 24 FU
|
-16.67 percentage change in UFS-SSS score
Standard Deviation 65.793
|
-63.89 percentage change in UFS-SSS score
Standard Deviation 48.591
|
-80.56 percentage change in UFS-SSS score
Standard Deviation 17.347
|
SECONDARY outcome
Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU VisitPopulation: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 7: During the previous 3 months how distressed were you by "frequent nighttime urination"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 1
|
-37.50 percentage change in UFS-SSS score
Standard Deviation 32.691
|
-48.81 percentage change in UFS-SSS score
Standard Deviation 47.237
|
-18.52 percentage change in UFS-SSS score
Standard Deviation 37.680
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to On-Drug Course 2
|
-43.52 percentage change in UFS-SSS score
Standard Deviation 39.917
|
-69.70 percentage change in UFS-SSS score
Standard Deviation 64.039
|
-33.33 percentage change in UFS-SSS score
Standard Deviation 52.705
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 2
|
-32.41 percentage change in UFS-SSS score
Standard Deviation 43.789
|
-66.67 percentage change in UFS-SSS score
Standard Deviation 66.667
|
-61.67 percentage change in UFS-SSS score
Standard Deviation 43.938
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 7 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Course 2 Week 24 FU
|
-27.38 percentage change in UFS-SSS score
Standard Deviation 63.230
|
-52.08 percentage change in UFS-SSS score
Standard Deviation 55.946
|
-58.33 percentage change in UFS-SSS score
Standard Deviation 11.785
|
SECONDARY outcome
Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Week 24 FU VisitPopulation: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
UFS-SSS is an 8 question assessment tool used to measure symptom severity and has been validated as a three month look back questionnaire. The participant answered UFS-SSS subscale question 8: During the previous 3 months how distressed were you by "feeling fatigued"? using a 5-point scale where 1=Not at all to 5=A very great deal. A negative percentage change from Baseline indicates improvement.
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to On-Drug Course 2
|
-53.70 percentage change in UFS-SSS score
Standard Deviation 22.864
|
-64.58 percentage change in UFS-SSS score
Standard Deviation 41.458
|
-43.75 percentage change in UFS-SSS score
Standard Deviation 43.814
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 2
|
-53.70 percentage change in UFS-SSS score
Standard Deviation 19.145
|
-70.45 percentage change in UFS-SSS score
Standard Deviation 37.889
|
-53.57 percentage change in UFS-SSS score
Standard Deviation 44.320
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Week 18 Course 1
|
-61.67 percentage change in UFS-SSS score
Standard Deviation 21.588
|
-58.89 percentage change in UFS-SSS score
Standard Deviation 53.030
|
-31.82 percentage change in UFS-SSS score
Standard Deviation 51.750
|
|
Percentage Change in the Individual UFS-SSS Subscale Score Question 8 From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Week 24 FU Visit
Percentage CFB to Course 2 Week 24 FU
|
-42.86 percentage change in UFS-SSS score
Standard Deviation 51.015
|
-53.70 percentage change in UFS-SSS score
Standard Deviation 35.627
|
-56.25 percentage change in UFS-SSS score
Standard Deviation 34.275
|
SECONDARY outcome
Timeframe: Baseline (No treatment period) to the end of 18-weeks Treatment Course 1, On-drug Course 2, the end of 18-weeks Treatment Course 2 and the Course 2 Off-drugPopulation: ITT population consisted of all participants who were randomized and received study drug. Number analyzed is the number of participants with data available for analysis at the given time-point.
The total uterine fibroid volume was measured by Magnetic Resonance Imaging (MRI). A negative percentage change from Baseline indicates improvement.
Outcome measures
| Measure |
Telapristone Acetate 6 mg
n=12 Participants
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 Participants
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 Participants
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug
Percentage CFB to Week 18 Course 1
|
-23.61 percentage change in fibroid volume
Standard Deviation 26.553
|
-38.91 percentage change in fibroid volume
Standard Deviation 20.318
|
1.34 percentage change in fibroid volume
Standard Deviation 18.576
|
|
Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug
Percentage CFB to On-Drug Course 2
|
-29.41 percentage change in fibroid volume
Standard Deviation 34.754
|
-50.10 percentage change in fibroid volume
Standard Deviation 25.048
|
11.88 percentage change in fibroid volume
Standard Deviation 56.516
|
|
Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug
Percentage CFB to Week 18 Course 2
|
-29.41 percentage change in fibroid volume
Standard Deviation 34.754
|
-50.10 percentage change in fibroid volume
Standard Deviation 25.048
|
11.88 percentage change in fibroid volume
Standard Deviation 56.516
|
|
Percentage Change in Total Uterine Fibroid Volume From Baseline to the End of Treatment Courses 1 and 2, On-drug Course 2 and the Course 2 Off-drug
Percentage CFB to Course 2 Off-drug
|
-31.51 percentage change in fibroid volume
Standard Deviation 31.108
|
-44.72 percentage change in fibroid volume
Standard Deviation 28.406
|
-11.26 percentage change in fibroid volume
Standard Deviation 37.048
|
Adverse Events
Telapristone Acetate 6 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Telapristone Acetate 12 mg
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telapristone Acetate 6 mg
n=12 participants at risk
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 participants at risk
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 participants at risk
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Investigations
Hepatic enzyme increased
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
Other adverse events
| Measure |
Telapristone Acetate 6 mg
n=12 participants at risk
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
|
Telapristone Acetate 12 mg
n=17 participants at risk
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
Placebo
n=14 participants at risk
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
11.8%
2/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
28.6%
4/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
14.3%
2/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
11.8%
2/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
General disorders
Hot flush
|
16.7%
2/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
29.4%
5/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
General disorders
Chest pain
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
General disorders
Fatigue
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
General disorders
Lethargy
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
General disorders
Night sweats
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Immune system disorders
Asthma
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Bacterial vaginosis
|
16.7%
2/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
23.5%
4/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
3/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
14.3%
2/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Trichomoniasis
|
16.7%
2/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
14.3%
2/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Fungal infection
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Pharyngitis streptococcal
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
14.3%
2/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Ear infection
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Pharyngitis
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Skin infection
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Injury, poisoning and procedural complications
Dermatitis contact
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Investigations
Blood pressure increased
|
16.7%
2/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Investigations
Weight increased
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Investigations
Blood glucose increased
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Investigations
Smear cervix abnormal
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
21.4%
3/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
2/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
14.3%
2/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
14.3%
2/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
14.3%
2/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
14.3%
2/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
17.6%
3/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
35.7%
5/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Renal and urinary disorders
Pollakiuria
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
33.3%
4/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
47.1%
8/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
11.8%
2/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
11.8%
2/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Reproductive system and breast disorders
Breast mass
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Reproductive system and breast disorders
Coital bleeding
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Reproductive system and breast disorders
Libido decreased
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Reproductive system and breast disorders
Tubo-ovarian abscess
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Reproductive system and breast disorders
Vulva cyst
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiac chest pain
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Skin and subcutaneous tissue disorders
Acne
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Vascular disorders
Dizziness
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
14.3%
2/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Vascular disorders
Dizziness postural
|
16.7%
2/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
7.1%
1/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
|
Vascular disorders
Vaginal haemorrhage
|
0.00%
0/12 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
5.9%
1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
0.00%
0/14 • From first dose of study drug through 30 days after the last dose of study drug (approximately 46 weeks)
Safety population consisted of all participants who were randomized, received study drug, and had some post-baseline safety data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER