Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)
A Double-blind Randomized Extension Study to Assess the Long-term Efficacy and Safety of Linzagolix in Subjects With Endometriosis-associated Pain
1 other identifier
interventional
356
9 countries
47
Brief Summary
The primary objective of this extension study is to assess the maintenance of efficacy of linzagolix administered orally once daily for up to an additional 6 months (for up to 12 months of treatment in total) in women who have already completed 6 months of linzagolix treatment at a dose of 75 mg alone or of 200 mg in combination with ABT (E2 1 mg / NETA 0.5 mg), in the management of moderate to severe endometriosis-associated pain (EAP) in women with surgically confirmed endometriosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2020
Typical duration for phase_3
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 5, 2020
CompletedFirst Submitted
Initial submission to the registry
April 3, 2020
CompletedFirst Posted
Study publicly available on registry
April 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2022
CompletedResults Posted
Study results publicly available
April 30, 2024
CompletedApril 2, 2025
March 1, 2024
2.5 years
April 3, 2020
April 3, 2024
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dysmenorrhea
Proportion of subjects with reduction of DYS (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12
6-month extension study treatment period (from Month 6 to Month 12)
Non-menstrual Pelvic Pain
Proportion of subjects with reduction of NMPP (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12
6-month extension study treatment period (from Month 6 to Month 12)
Study Arms (2)
Linzagolix 75 mg
EXPERIMENTALLinzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)
EXPERIMENTALInterventions
For oral administration once daily
For oral administration once daily
For oral administration once daily
For oral administration once daily
Eligibility Criteria
You may qualify if:
- The subject must have:
- completed the 6-month treatment in the main study.
- agree to continue to use only the analgesic rescue medication permitted by the protocol during the Treatment and Follow-up Periods.
- To continue to comply with the requirements of the study protocol for the duration of the extension study.
You may not qualify if:
- The subject will be excluded if she:
- Is pregnant or breast feeding or is planning a pregnancy within the duration of the of the study (including the Follow-up Period).
- likely to require treatment during the study with any of the restricted medications
- has any other clinically significant gynecologic condition identified during the main study on transvaginal ultrasound (TVUS), on endometrial biopsy or at the manual breast examination, which might interfere with the study efficacy and safety objectives.
- met any of the main study discontinuation criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Choice Research, LLC/ ID # 609
Dothan, Alabama, 36303, United States
Universal Axon - Homestead, LLC/ ID # 620
Homestead, Florida, 33030, United States
Stedman Clinical Trials/ ID # 612
Tampa, Florida, 33613, United States
Advanced Specialty Research/ ID # 610
Nampa, Idaho, 83687, United States
Women's & Family Care, LLC dba GTC Research/ ID # 608
Shawnee Mission, Kansas, 66218, United States
Southern Clinical Research / ID # 611
Metairie, Louisiana, 70001, United States
Chattanooga Medical Research LLC/ ID# 602
Chattanooga, Tennessee, 37404, United States
Tanner Clinic/ ID # 624
Layton, Utah, 84041, United States
Salzburger Landeskliniken / ID # 105
Salzburg, 5020, Austria
Multiprofile Hospital for Active Treatment Sliven/ ID # 131
Sliven, 8800, Bulgaria
MHAT Dr. Bratan Shukerov / ID #138
Smolyan, Bulgaria
Medical Centre Excelsior /ID # 135
Sofia, 1407, Bulgaria
Group Practice for Specialized Medical Assistance in GINART/ ID # 132
Sofia, 1606, Bulgaria
University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133
Sofia, 1797, Bulgaria
Gynekologicko - Porodnicka Ambulance/ ID # 162
Tábor, 39003, Czechia
Gynekologie MU Dr.Lubomir Mikulasek / ID # 160
Újezd nad Lesy, 19016, Czechia
Clinique Pasteur / ID # 206
Toulouse, 31076, France
Lubelskie Centrum Diagnostyczne/ ID # 402
Świdnik, Lublin Voivodeship, 21-040, Poland
Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404
Bialystok, Podlaskie Voivodeship, 15-224, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411
Katowice, 40-301, Poland
Clinical Medical Research sp. Z o. O/ ID # 406
Katowice, 40-628, Poland
Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407
Katowice, 40-851, Poland
Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405
Lublin, 20-064, Poland
Centrum Medyczne Chodźki Lublin/ ID # 403
Lublin, 20-093, Poland
VITA LONGA Sp. z o.o./ ID # 408
Lublin, 20-093, Poland
Centrum Ginekologii Endokrynologii i Medycyny Rozrodu "Artemida"/ ID # 409
Olsztyn, 10-357, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410
Przemyśl, 37-700, Poland
Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401
Warsaw, 02-929, Poland
Quantum Medical Center SRL/ ID # 353
Bucharest, 12071, Romania
Centrul Medical EUROMED/ ID # 351
Bucharest, 20764, Romania
Spitalul Clinic "Nicolae Malaxa"/ ID # 352
Bucharest, 22448, Romania
Sp Cl de Obstetrica si Ginecologie "Prof. Dr. Panait Sirbu"/ ID # 354
Bucharest, 60251, Romania
Gine Plus SRL Cluj- Napoca/ ID # 357
Cluj-Napoca, 400698, Romania
Centrul Medical GALENUS/ ID # 355
Târgu Mureş, 540236, Romania
Hospital Regional Universitario de Málaga/ ID # 303
Málaga, 29010, Spain
Hospital General Universitario Reina Sofia/ ID # 304
Murcia, 30003, Spain
City clinical maternity hospital №1/ ID # 502
Chernivtsi, 58003, Ukraine
Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506
Ivano-Frankivsk, 76018, Ukraine
Kyiv City Maternity Hospital #6/ ID # 504
Kyiv, 02125, Ukraine
Medical center of LLC "Medical Center "Verum"/ ID # 503
Kyiv, 03039, Ukraine
Institute of Pediatrics Obstetrics and Gynecology/ ID # 508
Kyiv, 04050, Ukraine
Kyiv City Clinical Hospital #9/ ID # 501
Kyiv, 04112, Ukraine
Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509
Kyiv, 04210, Ukraine
Ternopil' Communal City Hospital#2 / ID # 511
Ternopil, 46400, Ukraine
Vinnytsia City Clinical Hospital "Center of Mother and the Child "/ ID # 510
Vinnytsia, 21019, Ukraine
Zaporizhzhya Regional Clinical Hospital/ ID # 505
Zaporizhzhya, 69000, Ukraine
Maternity Hospital № 3/ ID # 507
Zaporizhzhya, 69071, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Division
- Organization
- Kissei Pharmaceutical Co., Ltd
Study Officials
- STUDY DIRECTOR
Lecomte
ObsEva SA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2020
First Posted
April 6, 2020
Study Start
March 5, 2020
Primary Completion
September 15, 2022
Study Completion
December 15, 2022
Last Updated
April 2, 2025
Results First Posted
April 30, 2024
Record last verified: 2024-03