Trial Outcomes & Findings for Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (NCT NCT04372121)
NCT ID: NCT04372121
Last Updated: 2025-04-02
Results Overview
Monthly Severity Data of dysmenorrhea (DYS) at Month 6 were measured on a 4-point (0: No pain, 1: Mild pain, 2: Moderate pain, 3: Severe pain) Verbal Rating Scale (VRS). The "Mean±SD" of Monthly Severity Data for each treatment arm were calculated and provided as the efficacy data.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
6 Months
Results posted on
2025-04-02
Participant Flow
Of the 85 subjects randomized in the Edelweiss 2 study, 37 completed the 6-month treatment. Of the 37 subjects, 30 subjects opted to participate in the current extension study (7 from Placebo, 13 from LGX 75 mg, and 10 from LGX 200 mg+ABT). At entry into the extension study, the 7 subjects in the placebo group were re-randomized to an active LGX group (PBO/LGX 75 mg: 3, PBO/LGX 200 mg+ABT: 4). Subjects receiving LGX during Edelweiss 2 study, continued treatment as randomized in the main study.
Subjects who received placebo in the main study were randomized in a 1:1 ratio to either linzagolix 75 mg alone (with ABT-matching placebo) or linzagolix 200 mg with ABT, as per the main study randomization schedule.
Participant milestones
| Measure |
LGX 75 mg
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\] Same treatment as the main study
|
LGX 200 mg+ABT
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 200 mg tab.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\] Same treatment as the main study
|
Placebo/LGX 75 mg
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
|
Placebo/LGX 200 mg+ABT
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
2
|
2
|
Reasons for withdrawal
| Measure |
LGX 75 mg
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\] Same treatment as the main study
|
LGX 200 mg+ABT
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 200 mg tab.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\] Same treatment as the main study
|
Placebo/LGX 75 mg
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
|
Placebo/LGX 200 mg+ABT
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
0
|
0
|
|
Overall Study
Study termination
|
6
|
5
|
1
|
1
|
|
Overall Study
Hysterectomy planned
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain
Baseline characteristics by cohort
| Measure |
LGX 75 mg
n=13 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\] Same treatment as the main study
|
LGX 200 mg+ABT
n=10 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 200 mg tab.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\] Same treatment as the main study
|
Placebo/LGX 75 mg
n=3 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
|
Placebo/LGX 200 mg+ABT
n=4 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
33.6 Years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
30.6 Years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
29.0 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
31.5 Years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
31.9 Years
STANDARD_DEVIATION 6.7 • n=21 Participants
|
|
Age, Customized
|
34.0 Years
n=5 Participants
|
30.5 Years
n=7 Participants
|
31.0 Years
n=5 Participants
|
33.5 Years
n=4 Participants
|
32.0 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
8 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
Weight
|
80.992 kg
STANDARD_DEVIATION 14.425 • n=5 Participants
|
76.446 kg
STANDARD_DEVIATION 22.398 • n=7 Participants
|
72.910 kg
STANDARD_DEVIATION 29.701 • n=5 Participants
|
76.143 kg
STANDARD_DEVIATION 27.300 • n=4 Participants
|
77.979 kg
STANDARD_DEVIATION 18.972 • n=21 Participants
|
|
BMI
|
29.650 kg/m2
STANDARD_DEVIATION 4.27 • n=5 Participants
|
28.390 kg/m2
STANDARD_DEVIATION 9.01 • n=7 Participants
|
28.230 kg/m2
STANDARD_DEVIATION 9.46 • n=5 Participants
|
27.300 kg/m2
STANDARD_DEVIATION 6.86 • n=4 Participants
|
28.770 kg/m2
STANDARD_DEVIATION 6.67 • n=21 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: Of the 37 subjects who completed the main study (NCT03986944), 30 subjects participated in the extension study (NCT04372121). Of these 30, there were no subjects who had the Monthly Severity Data of DYS and/or NMPP on Day 1 or Month 12 to evaluate the efficacy but there were 5 subjects that had Monthly Severity Data on Month 6.
Monthly Severity Data of dysmenorrhea (DYS) at Month 6 were measured on a 4-point (0: No pain, 1: Mild pain, 2: Moderate pain, 3: Severe pain) Verbal Rating Scale (VRS). The "Mean±SD" of Monthly Severity Data for each treatment arm were calculated and provided as the efficacy data.
Outcome measures
| Measure |
LGX 75 mg
n=1 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\] Same treatment as the main study
|
LGX 200 mg+ABT
n=1 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 200 mg tab.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\] Same treatment as the main study
|
Placebo/LGX 75 mg
n=2 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
|
Placebo/LGX 200 mg+ABT
n=1 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
|
|---|---|---|---|---|
|
Dysmenorrhea
|
2.0 score on a scale
Standard Deviation 0.0
|
2.0 score on a scale
Standard Deviation 0.0
|
2.5 score on a scale
Standard Deviation 0.5
|
2.0 score on a scale
Standard Deviation 0.0
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: Of the 37 subjects who completed the main study (NCT03986944), 30 subjects participated in the extension study (NCT04372121). Of these 30, there were no subjects who had the Monthly Severity Data of DYS and/or NMPP on Day 1 or Month 12 to evaluate the efficacy but there were 5 subjects that had Monthly Severity Data on Month 6.
Monthly Severity Data of non-menstrual pelvic pain (NMPP) at Month 6 were measured on a 4-point (0: No pain, 1: Mild pain, 2: Moderate pain, 3: Severe pain) Verbal Rating Scale (VRS). The "Mean±SD" of Monthly Severity Data for each treatment arm were calculated and provided as the efficacy data.
Outcome measures
| Measure |
LGX 75 mg
n=1 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\] Same treatment as the main study
|
LGX 200 mg+ABT
n=1 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 200 mg tab.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\] Same treatment as the main study
|
Placebo/LGX 75 mg
n=2 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
|
Placebo/LGX 200 mg+ABT
n=1 Participants
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
|
|---|---|---|---|---|
|
Non-menstrual Pelvic Pain
|
1.0 score on a scale
Standard Deviation 0.0
|
2.0 score on a scale
Standard Deviation 0.0
|
2.5 score on a scale
Standard Deviation 0.5
|
2.0 score on a scale
Standard Deviation 0.0
|
Adverse Events
LGX 75 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
LGX 200 mg+ABT
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo/LGX 75 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo/LGX 200 mg+ABT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LGX 75 mg
n=13 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\] Same treatment as the main study
|
LGX 200 mg+ABT
n=10 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 200 mg tab.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\] Same treatment as the main study
|
Placebo/LGX 75 mg
n=3 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
|
Placebo/LGX 200 mg+ABT
n=4 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Gallbladder polyp
|
7.7%
1/13 • Number of events 1 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/10 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/3 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/4 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
Other adverse events
| Measure |
LGX 75 mg
n=13 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6 months\] Same treatment as the main study
|
LGX 200 mg+ABT
n=10 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 200 mg tab.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x ABT cap. (E2 1 mg / NETA 0.5 mg)
\[Extension study: 6 months\] Same treatment as the main study
|
Placebo/LGX 75 mg
n=3 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap.
\[Extension study: 6months\] Same treatment as LGX 75 mg group in the extension study
|
Placebo/LGX 200 mg+ABT
n=4 participants at risk
\[Main study: 6 months\] The IMPs mentioned below were administered once daily orally.
* 1 x Linzagolix 75 mg placebo tab.
* 1 x Linzagolix 200 mg placebo tab.
* 1 x ABT placebo cap
\[Extension study: 6 months\] Same treatment as LGX 200 mg+ABT group in the extension study
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
20.0%
2/10 • Number of events 2 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/3 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/4 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Number of events 1 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/10 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/3 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/4 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/13 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
10.0%
1/10 • Number of events 1 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/3 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/4 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.7%
1/13 • Number of events 1 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/10 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/3 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/4 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/13 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
10.0%
1/10 • Number of events 1 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/3 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/4 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
7.7%
1/13 • Number of events 1 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/10 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/3 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/4 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
|
Investigations
Platelet count decreased
|
7.7%
1/13 • Number of events 1 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/10 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/3 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
0.00%
0/4 • Month 6 to Month 12 of the treatment period
An adverse event (AE) was defined as any untoward medical occurrence in a clinical trial subject administered an investigational medicinal product (IMP) and which did not necessarily have a causal relationship with this treatment. Therefore, AE was any unfavourable sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an IMP, whether or not considered related to the IMP.
|
Additional Information
Clinical Development Division
Kissei Pharmaceutical Co., Ltd
Phone: Email only
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place