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

Primary Purpose

Endometriosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
OBE2109
Sponsored by
ObsEva SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Pelvic Pain, Endometriosis, Dysmenorrhea, Dyspareunia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Key Inclusion Criteria:

  • The subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening.
  • The subject has moderate to severe endometriosis-associated pain during the screening period.
  • The subject has regular menstrual cycles.
  • The subject has a BMI ≥ 18 kg/m2 at the screening visit.

Key Exclusion Criteria:

  • The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
  • The subject had an interventional surgery for endometriosis performed within a period of 60 days before screening.
  • The subject did not respond to prior treatment with gonadotropin releasing hormone (GnRH) agonists or GnRH antagonists for endometriosis.
  • The subject has a history of, or known osteoporosis or other metabolic bone disease.
  • The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain.

Sites / Locations

  • Site reference ID 455
  • Site reference ID 439
  • Site reference ID 462
  • Site reference ID 405
  • Site reference ID 463
  • Site refenrec ID 469
  • Site reference ID 431
  • Site reference ID 440
  • Site reference ID 474
  • Site reference ID 450
  • Site reference ID 425
  • Site reference ID 410
  • Site reference ID 457
  • Site reference ID 418
  • Site reference ID 437
  • Site reference ID 458
  • Site reference ID 420
  • Site reference ID 441
  • Site reference ID 411
  • Site reference ID 424
  • Site reference ID 435
  • Site reference ID 423
  • Site reference ID 426
  • Site reference ID 442
  • Site reference ID 428
  • Site reference ID 459
  • Site reference ID 475
  • Site reference ID 465
  • Site reference ID 404
  • Site reference ID 456
  • Site reference ID 454
  • Site reference ID 453
  • Site reference ID 478
  • Site reference ID 445
  • Site reference ID 471
  • Site reference ID 430
  • Site reference ID 409
  • Site reference ID 468
  • Site reference ID 473
  • Site reference ID 427
  • Site reference ID 421
  • Site reference ID 466
  • Site reference ID 436
  • Site reference ID 433
  • Site reference ID 443
  • Site reference ID 472
  • Site reference ID 415
  • Site reference ID 414
  • Site reference ID 419
  • Site reference ID 449
  • Site reference ID 476
  • Site reference ID 408
  • Site reference ID 403
  • Site reference ID 429
  • Site reference ID 452
  • Site reference ID 461
  • Site reference ID 447
  • Site reference ID 460
  • Site reference ID 464
  • Site reference ID 413
  • Site reference ID 434
  • Site reference ID 479
  • Site reference ID 451
  • Site reference ID 402
  • Site reference ID 432
  • Site reference ID 422
  • Site reference ID 467
  • Site reference ID 407
  • Site reference ID 412
  • Site reference ID 417
  • Site reference ID 406
  • Site reference ID 101
  • Site reference ID 102
  • Site reference ID 104
  • Site reference ID 105
  • Site reference ID 103
  • Site reference ID 201
  • Site reference ID 202
  • Site reference ID 203
  • Site reference ID 204
  • Site reference ID 205
  • Site reference ID 305
  • Site reefrence ID 303
  • Site reference ID 301
  • Site reference ID 302
  • SIte reference ID 304

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

OBE2109 50 mg

OBE2109 75mg fixed dose (FD)

OBE2109 75mg titrated dose (TD)

OBE2109 100mg

OBE2109 200 mg

Placebo / OBE2109 100mg

Arm Description

Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.

Outcomes

Primary Outcome Measures

Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Overall Pelvic Pain Score (0-3 VRS)
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.

Secondary Outcome Measures

Change From Baseline to Week 12 in the Mean Overall Pelvic Pain Score (0-10 NRS)
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.
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
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.
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
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.
Change From Baseline to Week 12 in the Mean Dyspareunia Score (0-3 VRS)
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.
Change From Baseline to Week 12 in the Mean Dyschezia Score (0-10 NRS)
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.
Percentage of Subjects With Any Analgesics Use at Week 12
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).
Change From Baseline to Week 12 in the Mean Score of Endometriosis Health Profile-30 (EHP-30) Pain Domain
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.
Percentage of Subjects With Improvement in the Patient Global Impression of Change (PGIC) Score at Week 12
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.
Percentage of Subjects With an Endometriosis Severity Score of "Severe" at Week 12
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.
Change From Baseline to Week 12 in the Difficulty in Doing Daily Activities Mean Score
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.
Percentage Change From Baseline to Week 24 in Bone Mineral Density (BMD)
Change from baseline to Week 24 in BMD assessed by dual-energy X-ray absorptiometry (DXA) scan of LUMBAR SPINE.
Number of Non Benign Endometrial Biopsies at Week 24
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.
Change From Baseline to Week 24 in Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS)
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.
Percentage Change From Baseline to Week 24 in the Clinical Laboratory Assessments: LDL
This endpoint reports the change from baseline up to Week 24 in the clinical laboratory assessments: LDL cholesterol.
Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: HDL
This endpoint reports the change from baseline to week 24 in clinical laboratory assessments: HDL cholesterol.
Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: Triglycerides
This endpoint reports the change from baseline to week 24 in clinical laboratory assessments: triglycerides.

Full Information

First Posted
May 3, 2016
Last Updated
June 27, 2022
Sponsor
ObsEva SA
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1. Study Identification

Unique Protocol Identification Number
NCT02778399
Brief Title
A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis
Acronym
EDELWEISS
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 2b Dose-ranging Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis Associated Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ObsEva SA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to assess the efficacy and safety of a range of oral doses of OBE2109 versus placebo, in reducing endometriosis associated pain.
Detailed Description
The study is a prospective, dose-finding, randomized, parallel group, double-blind, placebo-controlled phase 2b study investigating the efficacy and safety of OBE2109 in the treatment of 330 women with moderate-to-severe endometriosis associated pain. Subject will be randomized to one of 6 treatment groups in a 1:1:1:1:1:1 ratio (1 placebo group, 5 dose groups with different dosage/regimen). Eligible subjects will be offered the opportunity to continue treatment with OBE2109 in an extension phase. Subjects who do not continue in the extension will enter the treatment-free follow-up phase of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Pelvic Pain, Endometriosis, Dysmenorrhea, Dyspareunia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OBE2109 50 mg
Arm Type
Experimental
Arm Title
OBE2109 75mg fixed dose (FD)
Arm Type
Experimental
Arm Title
OBE2109 75mg titrated dose (TD)
Arm Type
Experimental
Arm Title
OBE2109 100mg
Arm Type
Experimental
Arm Title
OBE2109 200 mg
Arm Type
Experimental
Arm Title
Placebo / OBE2109 100mg
Arm Type
Placebo Comparator
Arm Description
Participants received placebo for the first 12 weeks and were then crossed-over to active treatment with OBE2109 100mg for a further 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets for oral administration once daily
Intervention Type
Drug
Intervention Name(s)
OBE2109
Intervention Description
OBE2109 tablets for oral administration once daily
Primary Outcome Measure Information:
Title
Percentage of Subjects With 30% or Greater Reduction From Baseline to Week 12 in Mean Overall Pelvic Pain Score (0-3 VRS)
Description
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.
Time Frame
From baseline to week 12
Secondary Outcome Measure Information:
Title
Change From Baseline to Week 12 in the Mean Overall Pelvic Pain Score (0-10 NRS)
Description
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.
Time Frame
From baseline to week 12
Title
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
Description
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.
Time Frame
From baseline to week 12
Title
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
Description
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.
Time Frame
From baseline to week 12
Title
Change From Baseline to Week 12 in the Mean Dyspareunia Score (0-3 VRS)
Description
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.
Time Frame
From baseline to week 12
Title
Change From Baseline to Week 12 in the Mean Dyschezia Score (0-10 NRS)
Description
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.
Time Frame
From baseline to week 12
Title
Percentage of Subjects With Any Analgesics Use at Week 12
Description
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).
Time Frame
Up to week 12
Title
Change From Baseline to Week 12 in the Mean Score of Endometriosis Health Profile-30 (EHP-30) Pain Domain
Description
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.
Time Frame
From baseline to week 12
Title
Percentage of Subjects With Improvement in the Patient Global Impression of Change (PGIC) Score at Week 12
Description
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.
Time Frame
Up to week 12
Title
Percentage of Subjects With an Endometriosis Severity Score of "Severe" at Week 12
Description
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.
Time Frame
Up to week 12
Title
Change From Baseline to Week 12 in the Difficulty in Doing Daily Activities Mean Score
Description
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.
Time Frame
From baseline to week 12
Title
Percentage Change From Baseline to Week 24 in Bone Mineral Density (BMD)
Description
Change from baseline to Week 24 in BMD assessed by dual-energy X-ray absorptiometry (DXA) scan of LUMBAR SPINE.
Time Frame
From baseline up to week 24
Title
Number of Non Benign Endometrial Biopsies at Week 24
Description
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.
Time Frame
Week 24
Title
Change From Baseline to Week 24 in Endometrial Thickness Measured by Transvaginal Ultrasound (TVUS)
Description
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.
Time Frame
From baseline up to week 24
Title
Percentage Change From Baseline to Week 24 in the Clinical Laboratory Assessments: LDL
Description
This endpoint reports the change from baseline up to Week 24 in the clinical laboratory assessments: LDL cholesterol.
Time Frame
From baseline up to week 24
Title
Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: HDL
Description
This endpoint reports the change from baseline to week 24 in clinical laboratory assessments: HDL cholesterol.
Time Frame
From Baseline up to week 24
Title
Percentage Change From Baseline to Week 24 in Clinical Laboratory Assessments: Triglycerides
Description
This endpoint reports the change from baseline to week 24 in clinical laboratory assessments: triglycerides.
Time Frame
From baseline up to week 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: The subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening. The subject has moderate to severe endometriosis-associated pain during the screening period. The subject has regular menstrual cycles. The subject has a BMI ≥ 18 kg/m2 at the screening visit. Key Exclusion Criteria: The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study. The subject had an interventional surgery for endometriosis performed within a period of 60 days before screening. The subject did not respond to prior treatment with gonadotropin releasing hormone (GnRH) agonists or GnRH antagonists for endometriosis. The subject has a history of, or known osteoporosis or other metabolic bone disease. The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ObsEva SA
Organizational Affiliation
Geneva
Official's Role
Study Director
Facility Information:
Facility Name
Site reference ID 455
City
Chandler
State/Province
Arizona
Country
United States
Facility Name
Site reference ID 439
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Site reference ID 462
City
Arcadia
State/Province
California
Country
United States
Facility Name
Site reference ID 405
City
Chino
State/Province
California
Country
United States
Facility Name
Site reference ID 463
City
Huntington Park
State/Province
California
Country
United States
Facility Name
Site refenrec ID 469
City
Northridge
State/Province
California
Country
United States
Facility Name
Site reference ID 431
City
San Diego
State/Province
California
Country
United States
Facility Name
Site reference ID 440
City
Tustin
State/Province
California
Country
United States
Facility Name
Site reference ID 474
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Site reference ID 450
City
Lakewood
State/Province
Colorado
Country
United States
Facility Name
Site reference ID 425
City
Longmont
State/Province
Colorado
Country
United States
Facility Name
Site reference ID 410
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Site reference ID 457
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Site reference ID 418
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Site reference ID 437
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Site reference ID 458
City
Jensen Beach
State/Province
Florida
Country
United States
Facility Name
Site reference ID 420
City
Miami Lakes
State/Province
Florida
Country
United States
Facility Name
Site reference ID 441
City
Miami Springs
State/Province
Florida
Country
United States
Facility Name
Site reference ID 411
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site reference ID 424
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site reference ID 435
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site reference ID 423
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Site reference ID 426
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Site reference ID 442
City
Wellington
State/Province
Florida
Country
United States
Facility Name
Site reference ID 428
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site reference ID 459
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Site reference ID 475
City
Nampa
State/Province
Idaho
Country
United States
Facility Name
Site reference ID 465
City
Oak Brook
State/Province
Illinois
Country
United States
Facility Name
Site reference ID 404
City
Shawnee Mission
State/Province
Kansas
Country
United States
Facility Name
Site reference ID 456
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
Site reference ID 454
City
Marrero
State/Province
Louisiana
Country
United States
Facility Name
Site reference ID 453
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Site reference ID 478
City
Glen Burnie
State/Province
Maryland
Country
United States
Facility Name
Site reference ID 445
City
Fall River
State/Province
Massachusetts
Country
United States
Facility Name
Site reference ID 471
City
Fall River
State/Province
Massachusetts
Country
United States
Facility Name
Site reference ID 430
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Site reference ID 409
City
Bay City
State/Province
Michigan
Country
United States
Facility Name
Site reference ID 468
City
Saginaw
State/Province
Michigan
Country
United States
Facility Name
Site reference ID 473
City
Saginaw
State/Province
Michigan
Country
United States
Facility Name
Site reference ID 427
City
Southfield
State/Province
Michigan
Country
United States
Facility Name
Site reference ID 421
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Site reference ID 466
City
New York
State/Province
New York
Country
United States
Facility Name
Site reference ID 436
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Site reference ID 433
City
Morehead City
State/Province
North Carolina
Country
United States
Facility Name
Site reference ID 443
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Site reference ID 472
City
Franklin
State/Province
Ohio
Country
United States
Facility Name
Site reference ID 415
City
Tiffin
State/Province
Ohio
Country
United States
Facility Name
Site reference ID 414
City
Westerville
State/Province
Ohio
Country
United States
Facility Name
Site reference ID 419
City
Bryn Mawr
State/Province
Pennsylvania
Country
United States
Facility Name
Site reference ID 449
City
Jenkintown
State/Province
Pennsylvania
Country
United States
Facility Name
Site reference ID 476
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Site reference ID 408
City
Bristol
State/Province
Tennessee
Country
United States
Facility Name
Site reference ID 403
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Site reference ID 429
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Site reference ID 452
City
Austin
State/Province
Texas
Country
United States
Facility Name
Site reference ID 461
City
Beaumont
State/Province
Texas
Country
United States
Facility Name
Site reference ID 447
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Site reference ID 460
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Site reference ID 464
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Site reference ID 413
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site reference ID 434
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site reference ID 479
City
Houston
State/Province
Texas
Country
United States
Facility Name
Site reference ID 451
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Site reference ID 402
City
Schertz
State/Province
Texas
Country
United States
Facility Name
Site reference ID 432
City
Webster
State/Province
Texas
Country
United States
Facility Name
Site reference ID 422
City
Draper
State/Province
Utah
Country
United States
Facility Name
Site reference ID 467
City
Centreville
State/Province
Virginia
Country
United States
Facility Name
Site reference ID 407
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Site reference ID 412
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Site reference ID 417
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Site reference ID 406
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Site reference ID 101
City
Katowice
Country
Poland
Facility Name
Site reference ID 102
City
Katowice
Country
Poland
Facility Name
Site reference ID 104
City
Lublin
Country
Poland
Facility Name
Site reference ID 105
City
Lublin
Country
Poland
Facility Name
Site reference ID 103
City
Szczecin
Country
Poland
Facility Name
Site reference ID 201
City
Moscow
Country
Russian Federation
Facility Name
Site reference ID 202
City
Moscow
Country
Russian Federation
Facility Name
Site reference ID 203
City
Moscow
Country
Russian Federation
Facility Name
Site reference ID 204
City
Moscow
Country
Russian Federation
Facility Name
Site reference ID 205
City
Saint Petersburg
Country
Russian Federation
Facility Name
Site reference ID 305
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
Site reefrence ID 303
City
Kyiv
Country
Ukraine
Facility Name
Site reference ID 301
City
Kyiv
Country
Ukraine
Facility Name
Site reference ID 302
City
Kyiv
Country
Ukraine
Facility Name
SIte reference ID 304
City
Kyiv
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
32505383
Citation
Donnez J, Taylor HS, Taylor RN, Akin MD, Tatarchuk TF, Wilk K, Gotteland JP, Lecomte V, Bestel E. Treatment of endometriosis-associated pain with linzagolix, an oral gonadotropin-releasing hormone-antagonist: a randomized clinical trial. Fertil Steril. 2020 Jul;114(1):44-55. doi: 10.1016/j.fertnstert.2020.02.114. Epub 2020 Jun 4.
Results Reference
derived

Learn more about this trial

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

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