Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)
- Conditions
- Endometriosis
- Interventions
- Drug: Placebo capsule to match Add-back capsuleDrug: Add-back capsule (E2 1 mg / NETA 0.5 mg)
- Registration Number
- NCT04335591
- Lead Sponsor
- Kissei Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
This is a prospective, randomized, double-blind study. Subjects who have completed the 6-month Treatment Period in 18-OBE2109-003 - Edelweiss 3 study (herein referred to as main study) will be invited to enter the present extension study. Month 6 visit of the main study is a decision point for Subjects to either end treatment and enter a post-treatment follow up (part of the main study), or to opt for a 6-month treatment extension.
All subjects will receive once daily either linzagolix 75 mg alone (with ABT placebo) or 200 mg combined with ABT for 6 months. Subjects who received placebo during the main study will be randomized to either linzagolix 75 mg alone (with ABT placebo) or linzagolix 200 mg with ABT. Subjects who received active treatment during the main study will continue with the same treatment. Double-dummy design will be used in order to maintain the blinding of the study.
After end of treatment in the extension study (6-month treatment period: from Month 6 to Month 12), subjects will enter a post-treatment Follow-Up Period of 6 months with no investigational medicinal product (IMP) or - for subjects willing to continue treatment - a second extension study will be proposed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 356
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Linzagolix 75 mg 75 mg linzagolix tablet - Linzagolix 75 mg Placebo tablet to match 200 mg linzagolix tablet - Linzagolix 75 mg Placebo capsule to match Add-back capsule - Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) Add-back capsule (E2 1 mg / NETA 0.5 mg) - Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) 200 mg linzagolix tablet - Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) Placebo tablet to match 75 mg linzagolix tablet -
- Primary Outcome Measures
Name Time Method Dysmenorrhea 6-month extension study treatment period (from Month 6 to Month 12) Proportion of subjects with reduction of DYS (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12
Non-menstrual Pelvic Pain 6-month extension study treatment period (from Month 6 to Month 12) Proportion of subjects with reduction of NMPP (Month 3 MCT) and stable or decreased use of analgesics for EAP at Month 12
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (47)
Specjalistyczny Gabinet Lekarski Krzysztof Dynowski / ID # 401
🇵🇱Warsaw, Poland
Universal Axon - Homestead, LLC/ ID # 620
🇺🇸Homestead, Florida, United States
Stedman Clinical Trials/ ID # 612
🇺🇸Tampa, Florida, United States
Tanner Clinic/ ID # 624
🇺🇸Layton, Utah, United States
Kyiv City Center of Reproductive and Perinatal Medicine/ ID # 509
🇺🇦Kyiv, Ukraine
Kyiv City Maternity Hospital #6/ ID # 504
🇺🇦Kyiv, Ukraine
Choice Research, LLC/ ID # 609
🇺🇸Dothan, Alabama, United States
Advanced Specialty Research/ ID # 610
🇺🇸Nampa, Idaho, United States
Chattanooga Medical Research LLC/ ID# 602
🇺🇸Chattanooga, Tennessee, United States
Southern Clinical Research / ID # 611
🇺🇸Metairie, Louisiana, United States
Women's & Family Care, LLC dba GTC Research/ ID # 608
🇺🇸Shawnee Mission, Kansas, United States
Medical Centre Excelsior /ID # 135
🇧🇬Sofia, Bulgaria
Multiprofile Hospital for Active Treatment Sliven/ ID # 131
🇧🇬Sliven, Bulgaria
MHAT Dr. Bratan Shukerov / ID #138
🇧🇬Smolyan, Bulgaria
Group Practice for Specialized Medical Assistance in GINART/ ID # 132
🇧🇬Sofia, Bulgaria
Gynekologie MU Dr.Lubomir Mikulasek / ID # 160
🇨🇿Ujezd nad Lesy, Czechia
Gynekologicko - Porodnicka Ambulance/ ID # 162
🇨🇿Tábor, Czechia
University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133
🇧🇬Sofia, Bulgaria
Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411
🇵🇱Katowice, Poland
Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404
🇵🇱Białystok, Podlaskie, Poland
Clinical Medical Research sp. Z o. O/ ID # 406
🇵🇱Katowice, Poland
Lubelskie Centrum Diagnostyczne/ ID # 402
🇵🇱Świdnik, Lubelskie, Poland
Clinique Pasteur / ID # 206
🇫🇷Toulouse, France
Kotarski Jan Specjalistyczny Gabinet Ginekologiczno Polozniczy/ ID # 405
🇵🇱Lublin, Poland
Centrum Medyczne Chodźki Lublin/ ID # 403
🇵🇱Lublin, Poland
VITA LONGA Sp. z o.o./ ID # 408
🇵🇱Lublin, Poland
Centrum Ginekologii Endokrynologii i Medycyny Rozrodu "Artemida"/ ID # 409
🇵🇱Olsztyn, Poland
Centrul Medical EUROMED/ ID # 351
🇷🇴Bucuresti, Romania
Spitalul Clinic "Nicolae Malaxa"/ ID # 352
🇷🇴Bucharest, Romania
Quantum Medical Center SRL/ ID # 353
🇷🇴Bucharest, Romania
Gine Plus SRL Cluj- Napoca/ ID # 357
🇷🇴Cluj-Napoca, Romania
Hospital General Universitario Reina Sofia/ ID # 304
🇪🇸Murcia, Spain
Centrul Medical GALENUS/ ID # 355
🇷🇴Târgu-Mureş, Romania
Ivano-Frankivsk regional perinatal center, Family planning center/ ID # 506
🇺🇦Ivano-Frankivs'k, Ukraine
Hospital Regional Universitario de Málaga/ ID # 303
🇪🇸Málaga, Spain
Institute of Pediatrics Obstetrics and Gynecology/ ID # 508
🇺🇦Kyiv, Ukraine
Medical center of LLC "Medical Center "Verum"/ ID # 503
🇺🇦Kyiv, Ukraine
Kyiv City Clinical Hospital #9/ ID # 501
🇺🇦Kyiv, Ukraine
Maternity Hospital â„– 3/ ID # 507
🇺🇦Zaporizhzhya, Ukraine
Zaporizhzhya Regional Clinical Hospital/ ID # 505
🇺🇦Zaporizhzhya, Ukraine
Vinnytsia City Clinical Hospital "Center of Mother and the Child "/ ID # 510
🇺🇦Vinnytsia, Ukraine
Ternopil' Communal City Hospital#2 / ID # 511
🇺🇦Ternopil, Ukraine
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu/ ID # 410
🇵🇱Przemyśl, Poland
Salzburger Landeskliniken / ID # 105
🇦🇹Salzburg, Austria
Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407
🇵🇱Katowice, Poland
Sp Cl de Obstetrica si Ginecologie "Prof. Dr. Panait Sirbu"/ ID # 354
🇷🇴Bucuresti, Romania
City clinical maternity hospital â„–1/ ID # 502
🇺🇦Chernivtsi, Ukraine