Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.

Completed · 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

NCT03992846

Run by

Kissei Pharmaceutical Co., Ltd.

People needed

486

Starts

2019-06-13

Expected to finish

2022-04-01

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.

You may qualify if…

• The subject must have:
• Her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening.
• Moderate to severe endometriosis-associated pain during the screening period.
• Regular menstrual cycles.
• BMI ≥ 18 kg/m2 at the screening visit. -

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 treatment period of the study.
• Is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period.
• Has had a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening.
• Did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis.
• Has a history of, or known, osteoporosis or other metabolic bone disease.
• Has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.

Where it is running

• Choice Research, LLC/ ID # 609 — Dothan, Alabama, United States
• Southeast Clinical Research/ ID # 618 — Chiefland, Florida, United States
• Universal Axon - Homestead, LLC/ ID # 620 — Homestead, Florida, United States
• Multi-Specialty Research Associates, Inc./ ID # 625 — Lake City, Florida, United States
• Wellington Anti-Aging, LLC/ ID # 613 — Loxahatchee Groves, Florida, United States
• Adventura Clinical Research/ ID # 616 — Miramar, Florida, United States
• Stedman Clinical Trials/ ID # 612 — Tampa, Florida, United States
• Advanced Specialty Research/ ID # 610 — Nampa, Idaho, United States
• Affinity Clinical Research Institute/ ID # 622 — Oak Brook, Illinois, 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
• Quad Clinical Research LLC/ ID # 615 — St Louis, Missouri, United States
• The Center for Women's Health & Wellnes/ ID # 603 — Lawrenceville, New Jersey, United States
• PMG Research of Wilmington/ ID # 614 — Wilmington, North Carolina, United States
• UWCR - Lyndhurst Clinical Researc/ ID# 605 — Winston-Salem, North Carolina, United States
• Obstetrics & Gynecology Associates, Inc./ ID# 606 — Fairfield, Ohio, United States
• Invocare Medical Research & Healthcare Center/ ID # 607 — West Columbia, South Carolina, United States
• Chattanooga Medical Research LLC/ ID# 602 — Chattanooga, Tennessee, United States
• Next Innovative Clinical Research/ ID # 617 — Houston, Texas, United States
• Storks Research, LLC/ ID # 623 — Sugar Land, Texas, United States
• Tanner Clinic/ ID # 624 — Layton, Utah, United States
• Salzburger Landeskliniken / ID # 105 — Salzburg, Austria
• AKH Vienna University of Medicine Vienna / ID # 101 — Vienna, Austria
• AKH Vienna University of Medicine Vienna/ ID # 103 — Vienna, Austria
• Achieve Clinical Research/ ID # 601 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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