Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis (NCT NCT02778399)

NCT ID: NCT02778399

Last Updated: 2022-07-21

Results Overview

The primary efficacy endpoint of the study was a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean overall pelvic pain score, defined as the mean of daily pain scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period. The relevant time points are Baseline and Week 12.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 328 participants
• Primary outcome timeframe: From baseline to week 12
• Results posted on: 2022-07-21

Participant Flow

A total of 328 females were randomized at 62 sites in 4 countries: 48 sites in USA (177 subjects), 5 sites in Poland (67 subjects), 5 sites in Ukraine (73 subjects) and 4 sites in Russia (11 subjects).

716 subjects were screened and 328 were randomized; 327 were included in the safety set (1 not included as didn't receive study treatment). 323 subjects were included in the Full Analysis Set (FAS), 5 randomized subjects were excluded: 1 as per the safety set and 4 were prematurely discontinued at one US site due to the site's serious non-compliance to the protocol.

Participant milestones

Measure	Placebo / OBE2109 100mg Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg OBE2109 tablets for oral administration once daily	OBE2109 75mg FD OBE2109 tablets for oral administration once daily. FD = Fixed Dose	OBE2109 75mg TD OBE2109 tablets for oral administration once daily. TD = Titrated Dose	OBE2109 100mg OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Up to Week 12 Treatment Period STARTED	54	49	57	58	53	57
Up to Week 12 Treatment Period Included in SAFETY SET	54	49	57	58	52	57
Up to Week 12 Treatment Period Included in FAS	53	49	56	58	51	56
Up to Week 12 Treatment Period COMPLETED	45	45	53	51	45	49
Up to Week 12 Treatment Period NOT COMPLETED	9	4	4	7	8	8
Week 12 to Week 24 Treatment Period STARTED	45	45	53	51	45	49
Week 12 to Week 24 Treatment Period COMPLETED	37	41	48	46	39	42
Week 12 to Week 24 Treatment Period NOT COMPLETED	8	4	5	5	6	7

Reasons for withdrawal

Measure	Placebo / OBE2109 100mg Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg OBE2109 tablets for oral administration once daily	OBE2109 75mg FD OBE2109 tablets for oral administration once daily. FD = Fixed Dose	OBE2109 75mg TD OBE2109 tablets for oral administration once daily. TD = Titrated Dose	OBE2109 100mg OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Up to Week 12 Treatment Period Adverse Event	1	2	3	2	3	3
Up to Week 12 Treatment Period Withdrawal by Subject	5	2	1	4	2	3
Up to Week 12 Treatment Period Protocol Violation	0	0	0	0	1	0
Up to Week 12 Treatment Period Lost to Follow-up	3	0	0	0	0	2
Up to Week 12 Treatment Period other - reason not stated	0	0	0	1	2	0
Week 12 to Week 24 Treatment Period Adverse Event	2	0	2	1	3	2
Week 12 to Week 24 Treatment Period Withdrawal by Subject	3	2	0	3	2	2
Week 12 to Week 24 Treatment Period Protocol Violation	0	1	0	0	0	0
Week 12 to Week 24 Treatment Period Lost to Follow-up	2	1	0	1	0	2
Week 12 to Week 24 Treatment Period Pregnancy	1	0	2	0	0	0
Week 12 to Week 24 Treatment Period other - reason not stated	0	0	1	0	1	1

Baseline Characteristics

A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis

Baseline characteristics by cohort

Measure	Placebo / OBE2109 100mg n=53 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=49 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD n=56 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg TD n=58 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=51 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=56 Participants OBE2109 tablets for oral administration once daily	Total n=323 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	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants	49 Participants n=7 Participants	56 Participants n=5 Participants	58 Participants n=4 Participants	51 Participants n=21 Participants	56 Participants n=8 Participants	323 Participants n=8 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	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Continuous	32.4 years STANDARD_DEVIATION 5.78 • n=5 Participants	30.9 years STANDARD_DEVIATION 5.98 • n=7 Participants	32.0 years STANDARD_DEVIATION 6.83 • n=5 Participants	31.2 years STANDARD_DEVIATION 5.85 • n=4 Participants	33.0 years STANDARD_DEVIATION 5.78 • n=21 Participants	30.9 years STANDARD_DEVIATION 6.03 • n=8 Participants	31.7 years STANDARD_DEVIATION 6.06 • n=8 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	49 Participants n=7 Participants	56 Participants n=5 Participants	58 Participants n=4 Participants	51 Participants n=21 Participants	56 Participants n=8 Participants	323 Participants n=8 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	0 Participants n=8 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=8 Participants	27 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	18 Participants n=7 Participants	27 Participants n=5 Participants	25 Participants n=4 Participants	24 Participants n=21 Participants	23 Participants n=8 Participants	142 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	26 Participants n=7 Participants	26 Participants n=5 Participants	26 Participants n=4 Participants	23 Participants n=21 Participants	28 Participants n=8 Participants	154 Participants n=8 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	0 Participants n=8 Participants	0 Participants n=8 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	0 Participants n=8 Participants	0 Participants n=8 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	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	25 Participants n=8 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	46 Participants n=7 Participants	50 Participants n=5 Participants	50 Participants n=4 Participants	46 Participants n=21 Participants	52 Participants n=8 Participants	293 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 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	0 Participants n=8 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: From baseline to week 12

Population: Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5).

The primary efficacy endpoint of the study was a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean overall pelvic pain score, defined as the mean of daily pain scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The relevant time points are Baseline and Week 12.

Outcome measures

Measure	Placebo / OBE2109 100mg n=52 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=48 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=114 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=51 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=55 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Overall Pelvic Pain Score (0-3 VRS)	34.5 percentage of subjects	49.4 percentage of subjects	61.5 percentage of subjects	56.4 percentage of subjects	56.3 percentage of subjects	—

SECONDARY outcome

Timeframe: From baseline to week 12

Population: Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5).

This endpoint corresponds to the change from baseline to Week 12 in the mean overall pelvic pain score, defined as the mean of daily pain scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a Numerical Rating Scale (NRS) for pelvic pain of 0 (no pelvic pain) to 10 (worst pelvic pain imaginable). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The relevant time points are Baseline and Week 12.

Outcome measures

Measure	Placebo / OBE2109 100mg n=52 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=48 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=114 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=51 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=55 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Change From Baseline to Week 12 in the Mean Overall Pelvic Pain Score (0-10 NRS)	-1.17 score on a scale Interval -1.7 to -0.65	-1.75 score on a scale Interval -2.29 to -1.2	-2.15 score on a scale Interval -2.5 to -1.8	-2.06 score on a scale Interval -2.6 to -1.52	-2.14 score on a scale Interval -2.65 to -1.63	—

SECONDARY outcome

Timeframe: From baseline to week 12

Population: Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5).

This endpoint corresponds to a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean pelvic pain score for days with uterine bleeding/spotting, defined as the mean of daily pain scores on days with uterine bleeding/spotting recorded in electronic diary during the preceding 28 days (4-week period), assessed on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The relevant time points are Baseline and Week 12.

Outcome measures

Measure	Placebo / OBE2109 100mg n=52 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=48 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=114 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=51 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=55 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Pelvic Pain Scores (0-3 VRS) for Days With Uterine Bleeding	28.5 percentage of subjects	43.3 percentage of subjects	68.2 percentage of subjects	68.6 percentage of subjects	78.9 percentage of subjects	—

SECONDARY outcome

Timeframe: From baseline to week 12

Population: Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5).

This endpoint corresponds to a response at Week 12, with response defined as a reduction of 30% or greater from baseline in the mean pelvic pain score for days with no uterine bleeding, defined as the mean of daily pain scores on days with no uterine bleeding recorded in electronic diary during the preceding 28 days (4-week period) on a Verbal Rating Scale for pelvic pain of 0 (no pain) to 3 (severe pain). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The relevant time points are Baseline and Week 12.

Outcome measures

Measure	Placebo / OBE2109 100mg n=52 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=48 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=114 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=50 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=55 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Pelvic Pain Scores (0-3 VRS) for Days With no Uterine Bleeding	37.1 percentage of subjects	46.2 percentage of subjects	58.5 percentage of subjects	61.5 percentage of subjects	47.7 percentage of subjects	—

SECONDARY outcome

Timeframe: From baseline to week 12

Population: Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5).

This endpoint corresponds to the change from baseline to Week 12 in the mean dyspareunia score, defined as the mean of daily dyspareunia scores recorded in electronic diary during the preceding 28 days (4-week period), assessed on a 0-3 Verbal Rating Scale (VRS) for dyspareunia, with 0 representing "No discomfort during sexual intercourse" and 3 representing "I avoided sexual intercourse because of pain". The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The dyspareunia questionnaire also included an option "not applicable: I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse"; for scoring, answering "not applicable" was considered like a missing value.

The relevant time points are Baseline and Week 12.

Outcome measures

Measure	Placebo / OBE2109 100mg n=47 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=40 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=90 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=44 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=44 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Change From Baseline to Week 12 in the Mean Dyspareunia Score (0-3 VRS)	-0.39 score on a scale Interval -0.63 to -0.16	-0.62 score on a scale Interval -0.87 to -0.37	-0.59 score on a scale Interval -0.76 to -0.43	-0.66 score on a scale Interval -0.91 to -0.41	-0.79 score on a scale Interval -1.03 to -0.54	—

SECONDARY outcome

Timeframe: From baseline to week 12

Population: Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5).

This endpoint corresponds to the change from baseline to week 12 in the mean dyschezia score, defined as the mean of weekly dyschezia scores reported in electronic diary during the preceding 28 days (4-week period), assessed on a 0-10 Numerical Rating Scale for dyschezia, with 0 representing no pain and 10 representing the worst pain imaginable. The baseline mean score was calculated as the mean of weekly scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The relevant time points are Baseline and Week 12.

Outcome measures

Measure	Placebo / OBE2109 100mg n=52 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=48 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=113 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=50 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=55 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Change From Baseline to Week 12 in the Mean Dyschezia Score (0-10 NRS)	-0.78 score on a scale/week Interval -1.34 to -0.22	-1.55 score on a scale/week Interval -2.14 to -0.96	-1.87 score on a scale/week Interval -2.25 to -1.49	-1.97 score on a scale/week Interval -2.55 to -1.39	-1.7 score on a scale/week Interval -2.25 to -1.15	—

SECONDARY outcome

Timeframe: Up to week 12

Population: Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5).

This endpoint corresponds to the percentage of subjects at week 12 who recorded at least one pain medication intake in electronic diary during the preceding 28 days (4-week period).

Outcome measures

Measure	Placebo / OBE2109 100mg n=52 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=48 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=114 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=51 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=55 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Percentage of Subjects With Any Analgesics Use at Week 12	90.6 percentage of subjects Interval 78.6 to 96.2	77.1 percentage of subjects Interval 62.7 to 87.1	74.8 percentage of subjects Interval 65.7 to 82.1	68.8 percentage of subjects Interval 54.1 to 80.5	72.1 percentage of subjects Interval 58.4 to 82.7	—

SECONDARY outcome

Timeframe: From baseline to week 12

Population: Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5).

This endpoint corresponds to the change from baseline to Week 12 in the mean score of pain dimension of the EHP-30. The EHP-30 questionnaire was answered on electronic diary after activation by site staff during subject's monthly visits at site.

The EHP-30 pain dimension consists of 11 items each addressing the effect of pain on various activities in the past 4 weeks and each assessed on a 5-point scale (0=Never through to 4=Always). Scaled score was equalled to total of raw score of each item in scale divided by the maximum possible raw score of all the items in the dimension, multiplied by 100, resulting in a score on a scale from 0 (best possible health status) to 100 (worst possible health status).

The relevant time points are Baseline and Week 12.

Outcome measures

Measure	Placebo / OBE2109 100mg n=41 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=41 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=96 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=43 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=44 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Change From Baseline to Week 12 in the Mean Score of Endometriosis Health Profile-30 (EHP-30) Pain Domain	-7.4 score on a scale Interval -12.36 to -2.41	-18.5 score on a scale Interval -23.44 to -13.47	-18.9 score on a scale Interval -22.2 to -15.69	-19.4 score on a scale Interval -24.28 to -14.55	-20.9 score on a scale Interval -25.69 to -16.1	—

SECONDARY outcome

Timeframe: Up to week 12

Population: Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5).

The PGIC questionnaire consists of one question rated on a seven point scale (1="Very Much Improved" to 7="Very Much Worse"), with which the subject had to qualify her overall status since the start of the study. The PGIC was answered on electronic diary after activation by site staff during Week 12 visit at site.

This endpoint corresponds to the percentage of subjects with an "improvement" in the PGIC score, which includes all subjects who answered "Very much improved" or "Much improved" or "Minimally improved" at Week 12.

Outcome measures

Measure	Placebo / OBE2109 100mg n=43 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=42 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=98 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=43 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=46 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Percentage of Subjects With Improvement in the Patient Global Impression of Change (PGIC) Score at Week 12	65.1 percentage of subjects	78.6 percentage of subjects	80.6 percentage of subjects	86 percentage of subjects	95.7 percentage of subjects	—

SECONDARY outcome

Timeframe: Up to week 12

Population: Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5).

Subject was asked monthly on electronic diary to assess their impression of endometriosis severity, considering the preceding 4-weeks, with following possible answers: no symptoms, very mild, mild, moderate, severe. This question was programmed to raise automatically every 4 weeks on the subject electronic diary. Result reported here is the percentage of subjects who answered "severe" at week 12.

Outcome measures

Measure	Placebo / OBE2109 100mg n=52 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=48 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=114 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=51 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=55 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Percentage of Subjects With an Endometriosis Severity Score of "Severe" at Week 12	20.9 percentage of subjects	4.5 percentage of subjects	7.8 percentage of subjects	4.5 percentage of subjects	4.2 percentage of subjects	—

SECONDARY outcome

Timeframe: From baseline to week 12

Population: Number of subjects with available score in the respective group, from the Full Analysis Set (All randomized subjects who received at least one dose of study drug and had at least one assessment after first dose). Data for the 75mg group (FD) and 75mg titrated group (TD) were combined for the analyses of the first 12 weeks of treatment, as pre-specified in the protocol (section 9.5).

This endpoint corresponds to the change from baseline to Week 12 in the mean of daily scores for "difficulty in doing daily activities", assessed via electronic diary during the preceding 28 days (4-week period), on a Numerical Rating Scale (NRS) of 0 (no difficulty doing daily activities) to 10 (unable to do daily activities). The baseline mean score was calculated as the mean of daily scores recorded in electronic diary over the two complete menstrual cycles performed during the screening period.

The relevant time points are Baseline and Week 12.

Outcome measures

Measure	Placebo / OBE2109 100mg n=52 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=48 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=114 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=51 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=55 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg OBE2109 tablets for oral administration once daily
Change From Baseline to Week 12 in the Difficulty in Doing Daily Activities Mean Score	-1.17 score on a scale Interval -1.68 to -0.65	-1.65 score on a scale Interval -2.18 to -1.12	-2.06 score on a scale Interval -2.41 to -1.72	-1.88 score on a scale Interval -2.41 to -1.36	-1.99 score on a scale Interval -2.49 to -1.49	—

SECONDARY outcome

Timeframe: From baseline up to week 24

Population: Number of subjects with available BMD results at Week 24 in the respective group, from the Safety Set (all randomized subjects who received at least one dose of double-blind study drug irrespective of the treatment received).

Change from baseline to Week 24 in BMD assessed by dual-energy X-ray absorptiometry (DXA) scan of LUMBAR SPINE.

Outcome measures

Measure	Placebo / OBE2109 100mg n=34 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=38 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=45 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=42 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=37 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=38 Participants OBE2109 tablets for oral administration once daily
Percentage Change From Baseline to Week 24 in Bone Mineral Density (BMD)	-0.929 percentage change Interval -1.71 to -0.15	0.137 percentage change Interval -0.83 to 1.11	-0.798 percentage change Interval -1.57 to -0.03	-1.000 percentage change Interval -1.71 to -0.29	-1.365 percentage change Interval -2.14 to -0.59	-2.602 percentage change Interval -3.56 to -1.65

SECONDARY outcome

Timeframe: Week 24

Population: Number of subjects with available endometrial biopsy result at Week 24 in the respective group (excluding those with tissue unsatisfactory for evaluation), from the Safety Set (all randomized subjects who received at least one dose of double-blind study drug irrespective of the treatment received).

Any pathological changes in the endometrium at week 24 were assessed from endometrial biopsies. The number of non benign biopsies at Week 24 is presented per treatment arm.

Note: an isolated case of hyperplasia (without atypia) was observed at week 12 in the 200 mg group in a subject whose screening biopsy results were normal. A follow-up biopsy at week 24 revealed no abnormalities.

Outcome measures

Measure	Placebo / OBE2109 100mg n=11 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=16 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=19 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=17 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=13 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=4 Participants OBE2109 tablets for oral administration once daily
Number of Non Benign Endometrial Biopsies at Week 24	0 Non benign biopsies	0 Non benign biopsies	0 Non benign biopsies	0 Non benign biopsies	0 Non benign biopsies	0 Non benign biopsies

SECONDARY outcome

Timeframe: From baseline up to week 24

Population: Number of subjects with available TVUS result at Week 24 in the respective group, from the Safety Set (all randomized subjects who received at least one dose of double-blind study drug irrespective of the treatment received).

The endometrium thickness was measured by TVUS at screening and at Week 24 visit by the gynaecologist and result was recorded in mm. This endpoint reports the changes from baseline to Week 24 in the endometrial thickness.

Outcome measures

Measure	Placebo / OBE2109 100mg n=35 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=41 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=49 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=45 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=39 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=41 Participants OBE2109 tablets for oral administration once daily
Change From Baseline to Week 24 in Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS)	-3.1 mm Standard Deviation 4.64	-1.5 mm Standard Deviation 4.28	-2.3 mm Standard Deviation 4.15	-1.3 mm Standard Deviation 3.70	-1.6 mm Standard Deviation 4.56	-4.0 mm Standard Deviation 3.39

SECONDARY outcome

Timeframe: From baseline up to week 24

Population: Number of subjects with available laboratory LDL result at Week 24 in the respective group, from the Safety Set (all randomized subjects who received at least one dose of double-blind study drug irrespective of the treatment received).

This endpoint reports the change from baseline up to Week 24 in the clinical laboratory assessments: LDL cholesterol.

Outcome measures

Measure	Placebo / OBE2109 100mg n=39 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=40 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=48 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=47 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=41 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=41 Participants OBE2109 tablets for oral administration once daily
Percentage Change From Baseline to Week 24 in the Clinical Laboratory Assessments: LDL	1.7 percent change Standard Deviation 15.7	-0.3 percent change Standard Deviation 16.6	7.4 percent change Standard Deviation 55.2	7.3 percent change Standard Deviation 21.4	9.7 percent change Standard Deviation 20.7	10.3 percent change Standard Deviation 21.7

SECONDARY outcome

Timeframe: From Baseline up to week 24

Population: Number of subjects with available laboratory HDL result at Week 24 in the respective group, from the Safety Set (all randomized subjects who received at least one dose of double-blind study drug irrespective of the treatment received).

This endpoint reports the change from baseline to week 24 in clinical laboratory assessments: HDL cholesterol.

Outcome measures

Measure	Placebo / OBE2109 100mg n=39 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=40 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=48 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=47 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=41 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=41 Participants OBE2109 tablets for oral administration once daily
Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: HDL	5.5 percent change Standard Deviation 11.7	2.9 percent change Standard Deviation 12.9	3.8 percent change Standard Deviation 17.8	6.2 percent change Standard Deviation 24.1	5.6 percent change Standard Deviation 18.0	8.1 percent change Standard Deviation 14.7

SECONDARY outcome

Timeframe: From baseline up to week 24

Population: Number of subjects with available laboratory result for Triglycerides at Week 24 in the respective group, from the Safety Set (all randomized subjects who received at least one dose of double-blind study drug irrespective of the treatment received).

This endpoint reports the change from baseline to week 24 in clinical laboratory assessments: triglycerides.

Outcome measures

Measure	Placebo / OBE2109 100mg n=39 Participants Placebo: Placebo tablets for oral administration once daily. OBE2109: OBE2109 tablets for oral administration once daily. Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.	OBE2109 50mg n=40 Participants OBE2109 tablets for oral administration once daily	OBE2109 75mg FD + TD n=48 Participants OBE2109 tablets for oral administration once daily	OBE2109 100mg n=47 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=41 Participants OBE2109 tablets for oral administration once daily	OBE2109 200mg n=41 Participants OBE2109 tablets for oral administration once daily
Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: Triglycerides	17.9 percent change Standard Deviation 38.6	16.4 percent change Standard Deviation 41.3	5.2 percent change Standard Deviation 35.2	13.6 percent change Standard Deviation 45.0	20.5 percent change Standard Deviation 80.6	24.0 percent change Standard Deviation 57.7

Adverse Events

Placebo BL-Wk12

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

OBE2109 100mg Wk12-Wk24

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

OBE2109 50mg BL-Wk24

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

OBE2109 75mg FD BL-Wk24

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

OBE2109 75mg TD BL-Wk24

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

OBE2109 100mg BL-Wk24

Serious events: 3 serious events

Other events: 31 other events

Deaths: 0 deaths

OBE2109 200mg BL-Wk24

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo BL-Wk12 n=55 participants at risk Placebo: Placebo tablets for oral administration once daily. In this arm, participants received placebo for the first 12 weeks, from baseline (BL) to week 12 (Wk12). They were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks (from week 12 to week 24, reported in separate group).	OBE2109 100mg Wk12-Wk24 n=55 participants at risk OBE2109: OBE2109 tablets for oral administration once daily. In this arm, participants received placebo for the first 12 weeks from baseline to week 12 (reported in separate group). They were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks, from week 12 (Wk12) to week 24 (Wk24).	OBE2109 50mg BL-Wk24 n=49 participants at risk OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24)	OBE2109 75mg FD BL-Wk24 n=58 participants at risk OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24)	OBE2109 75mg TD BL-Wk24 n=56 participants at risk OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24)	OBE2109 100mg BL-Wk24 n=52 participants at risk OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24)	OBE2109 200mg BL-Wk24 n=57 participants at risk OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24)
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	0.00% 0/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	0.00% 0/56 • From baseline up to week 24	1.9% 1/52 • Number of events 1 • From baseline up to week 24	0.00% 0/57 • From baseline up to week 24
Gastrointestinal disorders Enterocolitis	0.00% 0/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	0.00% 0/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	0.00% 0/56 • From baseline up to week 24	1.9% 1/52 • Number of events 1 • From baseline up to week 24	0.00% 0/57 • From baseline up to week 24
Reproductive system and breast disorders Metrorrhagia	0.00% 0/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	0.00% 0/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	0.00% 0/56 • From baseline up to week 24	1.9% 1/52 • Number of events 1 • From baseline up to week 24	0.00% 0/57 • From baseline up to week 24
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	0.00% 0/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	0.00% 0/56 • From baseline up to week 24	0.00% 0/52 • From baseline up to week 24	1.8% 1/57 • Number of events 1 • From baseline up to week 24
Infections and infestations Pyelonephritis acute	0.00% 0/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	2.0% 1/49 • Number of events 1 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	0.00% 0/56 • From baseline up to week 24	0.00% 0/52 • From baseline up to week 24	0.00% 0/57 • From baseline up to week 24
Injury, poisoning and procedural complications Stab wound	1.8% 1/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	0.00% 0/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	0.00% 0/56 • From baseline up to week 24	0.00% 0/52 • From baseline up to week 24	0.00% 0/57 • From baseline up to week 24

Other adverse events

Measure	Placebo BL-Wk12 n=55 participants at risk Placebo: Placebo tablets for oral administration once daily. In this arm, participants received placebo for the first 12 weeks, from baseline (BL) to week 12 (Wk12). They were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks (from week 12 to week 24, reported in separate group).	OBE2109 100mg Wk12-Wk24 n=55 participants at risk OBE2109: OBE2109 tablets for oral administration once daily. In this arm, participants received placebo for the first 12 weeks from baseline to week 12 (reported in separate group). They were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks, from week 12 (Wk12) to week 24 (Wk24).	OBE2109 50mg BL-Wk24 n=49 participants at risk OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24)	OBE2109 75mg FD BL-Wk24 n=58 participants at risk OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24)	OBE2109 75mg TD BL-Wk24 n=56 participants at risk OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24)	OBE2109 100mg BL-Wk24 n=52 participants at risk OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24)	OBE2109 200mg BL-Wk24 n=57 participants at risk OBE2109 tablets for oral administration once daily, from baseline (BL) to week 24 (Wk24)
Investigations weight increased	0.00% 0/55 • From baseline up to week 24	1.8% 1/55 • From baseline up to week 24	4.1% 2/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	1.8% 1/56 • From baseline up to week 24	5.8% 3/52 • From baseline up to week 24	1.8% 1/57 • From baseline up to week 24
Gastrointestinal disorders abdominal pain upper	1.8% 1/55 • From baseline up to week 24	3.6% 2/55 • From baseline up to week 24	2.0% 1/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	1.8% 1/56 • From baseline up to week 24	7.7% 4/52 • From baseline up to week 24	1.8% 1/57 • From baseline up to week 24
Skin and subcutaneous tissue disorders acne	1.8% 1/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	4.1% 2/49 • From baseline up to week 24	5.2% 3/58 • From baseline up to week 24	3.6% 2/56 • From baseline up to week 24	0.00% 0/52 • From baseline up to week 24	1.8% 1/57 • From baseline up to week 24
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	2.0% 1/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	1.8% 1/56 • From baseline up to week 24	5.8% 3/52 • From baseline up to week 24	15.8% 9/57 • From baseline up to week 24
Musculoskeletal and connective tissue disorders back pain	0.00% 0/55 • From baseline up to week 24	1.8% 1/55 • From baseline up to week 24	6.1% 3/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	3.6% 2/56 • From baseline up to week 24	0.00% 0/52 • From baseline up to week 24	0.00% 0/57 • From baseline up to week 24
Investigations blood creatine phosphokinase increased	1.8% 1/55 • From baseline up to week 24	1.8% 1/55 • From baseline up to week 24	2.0% 1/49 • From baseline up to week 24	6.9% 4/58 • From baseline up to week 24	8.9% 5/56 • From baseline up to week 24	3.8% 2/52 • From baseline up to week 24	7.0% 4/57 • From baseline up to week 24
Infections and infestations bronchitis	0.00% 0/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	0.00% 0/49 • From baseline up to week 24	3.4% 2/58 • From baseline up to week 24	0.00% 0/56 • From baseline up to week 24	1.9% 1/52 • From baseline up to week 24	5.3% 3/57 • From baseline up to week 24
Nervous system disorders dizziness	0.00% 0/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	2.0% 1/49 • From baseline up to week 24	5.2% 3/58 • From baseline up to week 24	1.8% 1/56 • From baseline up to week 24	3.8% 2/52 • From baseline up to week 24	3.5% 2/57 • From baseline up to week 24
General disorders fatigue	0.00% 0/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	2.0% 1/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	0.00% 0/56 • From baseline up to week 24	7.7% 4/52 • From baseline up to week 24	3.5% 2/57 • From baseline up to week 24
Nervous system disorders headache	25.5% 14/55 • From baseline up to week 24	16.4% 9/55 • From baseline up to week 24	24.5% 12/49 • From baseline up to week 24	17.2% 10/58 • From baseline up to week 24	28.6% 16/56 • From baseline up to week 24	28.8% 15/52 • From baseline up to week 24	29.8% 17/57 • From baseline up to week 24
Vascular disorders hot flush	10.9% 6/55 • From baseline up to week 24	9.1% 5/55 • From baseline up to week 24	18.4% 9/49 • From baseline up to week 24	19.0% 11/58 • From baseline up to week 24	23.2% 13/56 • From baseline up to week 24	28.8% 15/52 • From baseline up to week 24	45.6% 26/57 • From baseline up to week 24
Infections and infestations influenza	0.00% 0/55 • From baseline up to week 24	1.8% 1/55 • From baseline up to week 24	2.0% 1/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	0.00% 0/56 • From baseline up to week 24	5.8% 3/52 • From baseline up to week 24	0.00% 0/57 • From baseline up to week 24
Psychiatric disorders libido decreased	0.00% 0/55 • From baseline up to week 24	1.8% 1/55 • From baseline up to week 24	0.00% 0/49 • From baseline up to week 24	1.7% 1/58 • From baseline up to week 24	0.00% 0/56 • From baseline up to week 24	0.00% 0/52 • From baseline up to week 24	5.3% 3/57 • From baseline up to week 24
Psychiatric disorders mood swings	9.1% 5/55 • From baseline up to week 24	1.8% 1/55 • From baseline up to week 24	4.1% 2/49 • From baseline up to week 24	1.7% 1/58 • From baseline up to week 24	5.4% 3/56 • From baseline up to week 24	5.8% 3/52 • From baseline up to week 24	3.5% 2/57 • From baseline up to week 24
Infections and infestations nasopharyngitis	5.5% 3/55 • From baseline up to week 24	1.8% 1/55 • From baseline up to week 24	16.3% 8/49 • From baseline up to week 24	12.1% 7/58 • From baseline up to week 24	7.1% 4/56 • From baseline up to week 24	3.8% 2/52 • From baseline up to week 24	1.8% 1/57 • From baseline up to week 24
Gastrointestinal disorders nausea	1.8% 1/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	6.1% 3/49 • From baseline up to week 24	3.4% 2/58 • From baseline up to week 24	3.6% 2/56 • From baseline up to week 24	7.7% 4/52 • From baseline up to week 24	12.3% 7/57 • From baseline up to week 24
General disorders pyrexia	0.00% 0/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	4.1% 2/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	1.8% 1/56 • From baseline up to week 24	1.9% 1/52 • From baseline up to week 24	5.3% 3/57 • From baseline up to week 24
Gastrointestinal disorders toothache	5.5% 3/55 • From baseline up to week 24	1.8% 1/55 • From baseline up to week 24	6.1% 3/49 • From baseline up to week 24	3.4% 2/58 • From baseline up to week 24	0.00% 0/56 • From baseline up to week 24	0.00% 0/52 • From baseline up to week 24	1.8% 1/57 • From baseline up to week 24
Infections and infestations urinary tract infection	0.00% 0/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	2.0% 1/49 • From baseline up to week 24	5.2% 3/58 • From baseline up to week 24	5.4% 3/56 • From baseline up to week 24	3.8% 2/52 • From baseline up to week 24	8.8% 5/57 • From baseline up to week 24
Reproductive system and breast disorders vulvovaginal dryness	0.00% 0/55 • From baseline up to week 24	0.00% 0/55 • From baseline up to week 24	0.00% 0/49 • From baseline up to week 24	0.00% 0/58 • From baseline up to week 24	1.8% 1/56 • From baseline up to week 24	3.8% 2/52 • From baseline up to week 24	5.3% 3/57 • From baseline up to week 24

Additional Information

Medical Responsible

Clinical Operations

Phone: +41 (0)22 552 1560

Email: clinicaltrials@obseva.ch

Results disclosure agreements

• Principal investigator is a sponsor employee The PI cannot disclose study information which is not publicly available without prior written consent of Sponsor.
• Publication restrictions are in place

Restriction type: OTHER