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

NCT04335591 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2025-04-02

Study results available
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Summary

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.

Conditions

  • Endometriosis

Interventions

DRUG

75 mg linzagolix tablet

For oral administration once daily

DRUG

200 mg linzagolix tablet

For oral administration once daily

DRUG

Placebo tablet to match 75 mg linzagolix tablet

For oral administration once daily

DRUG

Placebo tablet to match 200 mg linzagolix tablet

For oral administration once daily

DRUG

Add-back capsule (E2 1 mg / NETA 0.5 mg)

For oral administration once daily

DRUG

Placebo capsule to match Add-back capsule

For oral administration once daily

Sponsors & Collaborators

  • Kissei Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Lecomte · ObsEva SA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-05
Primary Completion
2022-09-15
Completion
2022-12-15
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Czechia
  • France
  • Poland
  • Romania
  • Spain
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04335591 on ClinicalTrials.gov