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

Phase 3

Completed

• Conditions: Endometriosis
• Interventions: Drug: 200 mg linzagolix tablet; Drug: 75 mg linzagolix tablet; Drug: Placebo tablet to match 200 mg linzagolix tablet; Drug: Add-back capsule (E2 1 mg / NETA 0.5 mg); Drug: Placebo tablet to match 75 mg linzagolix tablet; Drug: Placebo capsule to match Add-back capsule

• Registration Number: NCT03992846
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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).

Detailed Description

This is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose ABT (E2 1 mg/NETA 0.5 mg) versus placebo in the management of moderate to severe EAP in 450 women.

Eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). Subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.

Study Timeline

• Study Start: 2019-06-13
• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-20
• Primary Completion: 2021-10-18
• Study Completion: 2022-04-01
• Status Verified: 2022-06
• Results First Submitted: 2024-04-03
• Results First Submitted QC: 2024-05-01
• Results First Posted: 2024-05-29
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 486

Inclusion Criteria

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. -

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)	Placebo tablet to match 75 mg linzagolix tablet	-
Placebo	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)	-
Placebo	Placebo tablet to match 75 mg linzagolix tablet	-
Linzagolix 75 mg	Placebo tablet to match 200 mg linzagolix tablet	-
Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)	200 mg linzagolix tablet	-
Placebo	Placebo capsule to match Add-back capsule	-
Linzagolix 75 mg	75 mg linzagolix tablet	-

Primary Outcome Measures

Name	Time	Method
Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders	Baseline to Month 3	Percentage of subjects with reduction of 1.1 for DYS in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.
Reduction of Non-menstrual Pelvic Pain (NMPP) at Month 3 - Proportion of Responders	Baseline to Month 3	Percentage of subjects with reduction of 0.8 for NMPP in mean pelvic pain score within last 28 days prior to Month 3 or discontinuation, and stable or decreased use of analgesics for Endometriosis-associated pain (=EAP) within the same calendar days.

Trial Locations

Locations (71)

Achieve Clinical Research/ ID # 601; 🇺🇸 Birmingham, Alabama, United States

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

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