Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)

Completed · Phase 3 · Has a placebo group

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT04335591

Run by

Kissei Pharmaceutical Co., Ltd.

People needed

356

Starts

2020-03-05

Expected to finish

2022-12-15

Last updated by the study team

2025-04-02

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Choice Research, LLC/ ID # 609 — Dothan, Alabama, United States
• Universal Axon - Homestead, LLC/ ID # 620 — Homestead, Florida, United States
• Stedman Clinical Trials/ ID # 612 — Tampa, Florida, United States
• Advanced Specialty Research/ ID # 610 — Nampa, Idaho, United States
• Women's & Family Care, LLC dba GTC Research/ ID # 608 — Shawnee Mission, Kansas, United States
• Southern Clinical Research / ID # 611 — Metairie, Louisiana, United States
• Chattanooga Medical Research LLC/ ID# 602 — Chattanooga, Tennessee, United States
• Tanner Clinic/ ID # 624 — Layton, Utah, United States
• Salzburger Landeskliniken / ID # 105 — Salzburg, Austria
• Multiprofile Hospital for Active Treatment Sliven/ ID # 131 — Sliven, Bulgaria
• MHAT Dr. Bratan Shukerov / ID #138 — Smolyan, Bulgaria
• Medical Centre Excelsior /ID # 135 — Sofia, Bulgaria
• Group Practice for Specialized Medical Assistance in GINART/ ID # 132 — Sofia, Bulgaria
• University Multiprofile Hospital for Active Treatment "Sofiamed"/ ID # 133 — Sofia, Bulgaria
• Gynekologicko - Porodnicka Ambulance/ ID # 162 — Tábor, Czechia
• Gynekologie MU Dr.Lubomir Mikulasek / ID # 160 — Újezd nad Lesy, Czechia
• Clinique Pasteur / ID # 206 — Toulouse, France
• Lubelskie Centrum Diagnostyczne/ ID # 402 — Świdnik, Lublin Voivodeship, Poland
• Prywatna Klinika Ginekologiczno - Położnicza/ ID # 404 — Bialystok, Podlaskie Voivodeship, Poland
• Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Wilk/ ID # 411 — Katowice, Poland
• Clinical Medical Research sp. Z o. O/ ID # 406 — Katowice, Poland
• Niepubliczny Zaklad Opieki Zrowotnej GynCentrum/ ID # 407 — Katowice, Poland
• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.