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

Stopped early · 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

NCT04372121

Run by

Kissei Pharmaceutical Co., Ltd.

People needed

30

Starts

2020-03-23

Expected to finish

2021-02-16

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
• agreed to continue to use only the analgesic rescue medication permitted by the protocol during the Treatment and Follow-up Periods
• agreed 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
• meets any of the main study discontinuation criteria

Where it is running

• Applied Res Center of Ar / Id # 735 — Little Rock, Arkansas, United States
• Futura Research, Inc. / ID # 781 — Norwalk, California, United States
• Adv Womens Health Institute / ID # 761 — Greenwood Village, Colorado, United States
• Red Rocks OB/GYN / ID # 732 — Lakewood, Colorado, United States
• Dr. David I. Lubetkin, LLC / ID # 703 — Boca Raton, Florida, United States
• Coral Way Research / ID # 799 — Miami, Florida, United States
• La Salud Research Clinic, Inc. / ID # 824 — Miami, Florida, United States
• A Premier Medical Research of Florida, LLC / ID # 752 — Orange City, Florida, United States
• Clinical Associates of Orlando, LLC / ID # 779 — Orlando, Florida, United States
• Providea Health Partners LLC / ID # 734 — Evergreen Park, Illinois, United States
• Onyx Clinical Research / ID # 793 — Flint, Michigan, United States
• Valley OBGYN / ID # 704 — Saginaw, Michigan, United States
• ClinOhio Res Services, LLC / ID # 722 — Columbus, Ohio, United States
• Complete Healthcare for Women / ID # 801 — Columbus, Ohio, United States
• Hilltop OBGYN / ID # 711 — Franklin, Ohio, United States
• Clinical Research Associates Inc / ID # 802 — Nashville, Tennessee, United States
• Austin Area ObGyn PLLC / ID # 701 — Austin, Texas, United States
• OB/GYN North Austin / ID # 764 — Austin, Texas, United States
• HCWC dba DiscoveryClinical Trials / ID # 771 — Dallas, Texas, United States
• Signature Gyn Services / ID # 726 — Fort Worth, Texas, United States
• Medical Colleagues of Texas / ID # 819 — Katy, Texas, United States
• Maximos OB/GYN — League City, Texas, United States
• Physicians Research Options / ID # 766 — Draper, Utah, United States
• CARe Clinic / ID # 872 — Red Deer, Alberta, Canada
• Puerto Rico Medical Res Inc. / ID # 890 — Ponce, Puerto Rico

Full record on ClinicalTrials.gov

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