A Phase 3 Study to Confirm the Efficacy and Safety of Linzagolix to Treat Endometriosis-associated Pain
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Endometriosis
In brief
The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).
Key facts
- Study ID
- NCT03986944
- Run by
- Kissei Pharmaceutical Co., Ltd.
- People needed
- 85
- Starts
- 2019-05-23
- Expected to finish
- 2021-02-16
- Last updated by the study team
- 2025-04-02
Who can join
Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Mesa Obstetricians and Gyneocologists / ID # 790 — Mesa, Arizona, United States
- Precision Trials AZ, LLC / ID # 783 — Phoenix, Arizona, United States
- Quality of LIfe Medical & Research Center, LLC / ID # 813 — Tucson, Arizona, United States
- Visions Clinical Research-Tucson / ID # 754 — Tucson, Arizona, United States
- Lynn Institute of the Ozarks / ID # 826 — Little Rock, Arkansas, United States
- Applied Research Center of Arkansas / ID # 735 — Little Rock, Arkansas, United States
- Join Clinical Trials / ID # 778 — Huntington Park, California, United States
- Long Beach Clinical Trials, LLC / ID # 768 — Long Beach, California, United States
- Matrix Clinical Research / ID # 751 — Los Angeles, California, United States
- Futura Research, Org / ID # 781 — Norwalk, California, United States
- National Research Institute / ID # 805 — Panorama City, California, United States
- Precision Research Institute / ID # 792 — San Diego, California, United States
- MD Strategies Research Centers / ID # 765 — San Diego, California, United States
- Downtown Women's Health Care / ID # 718 — Denver, Colorado, United States
- Center for Women's Health / ID # 761 — Greenwood Village, Colorado, United States
- Physicians Research Options, LLC / Red Rocks Ob/Gyn / ID # 732 — Lakewood, Colorado, United States
- Dr. David I. Lubetkin, LLC / ID # 703 — Boca Raton, Florida, United States
- Helix Biomedics Clincial Research, LLC / ID # 750 — Boynton Beach, Florida, United States
- Accel Research Sites, DeLand Clinical Research Unit / ID # 713 — DeLand, Florida, United States
- Universal Axon Clinical Research / ID # 769 — Doral, Florida, United States
- Clinical Neuroscience Solutions, Inc. / ID # 773 — Jacksonville, Florida, United States
- South Florida Clinical Research Institute / ID # 747 — Margate, Florida, United States
- Coral Way Research / ID # 799 — Miami, Florida, United States
- Suncoast Research Group, LLC / ID # 756 — Miami, Florida, United States
- Birmingham OBGYN / ID # 740 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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