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GnRH Receptor Antagonist

Linzagolix 75 mg for Endometriosis

Phase 3
Waitlist Available
Research Sponsored by ObsEva SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
completed the 6-month treatment in the main study.
agree to continue to use only the analgesic rescue medication permitted by the protocol during the Treatment and Follow-up Periods.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 12
Awards & highlights

Study Summary

This trial is to see if the drug linzagolix, given for up to 12 months, is effective in reducing moderate to severe endometriosis-associated pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Dyschezia
Dysmenorrhea
Dyspareunia
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Linzagolix 75 mgExperimental Treatment3 Interventions
Group II: Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)Experimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
200 mg linzagolix tablet
2019
Completed Phase 3
~850
Placebo tablet to match 75 mg linzagolix tablet
2019
Completed Phase 3
~850
Add-back capsule (E2 1 mg / NETA 0.5 mg)
2019
Completed Phase 3
~850
Placebo capsule to match Add-back capsule
2019
Completed Phase 3
~850
Placebo tablet to match 200 mg linzagolix tablet
2019
Completed Phase 3
~850
75 mg linzagolix tablet
2019
Completed Phase 3
~850

Find a Location

Who is running the clinical trial?

ObsEva SALead Sponsor
13 Previous Clinical Trials
4,025 Total Patients Enrolled
4 Trials studying Endometriosis
929 Patients Enrolled for Endometriosis
Kissei Pharmaceutical Co., Ltd.Lead Sponsor
56 Previous Clinical Trials
6,818 Total Patients Enrolled
6 Trials studying Endometriosis
656 Patients Enrolled for Endometriosis
LecomteStudy DirectorObsEva SA
2 Previous Clinical Trials
571 Total Patients Enrolled
2 Trials studying Endometriosis
571 Patients Enrolled for Endometriosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)
2020. "Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain (EDELWEISS 6)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04335591.
~70 spots leftby Apr 2025
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