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GnRH Receptor Antagonist

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

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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-month extension study treatment period (from month 6 to month 12)
Awards & highlights
Pivotal Trial

Summary

This trial tests if continuing linzagolix, a daily pill, can keep reducing pain in women with severe endometriosis who have already been treated for some time. The medication aims to manage and lessen the pain caused by this condition. Linzagolix is a new oral medication under investigation for the treatment of endometriosis and uterine myomas.

Eligible Conditions
  • Endometriosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-month extension study treatment period (from month 6 to month 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month extension study treatment period (from month 6 to month 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dysmenorrhea
Non-menstrual Pelvic Pain
Secondary study objectives
Dyschezia
Dyspareunia
Interference of pain with the ability to perform daily activities
+4 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
Placebo capsule to match Add-back capsule
2019
Completed Phase 3
~850
75 mg linzagolix tablet
2019
Completed Phase 3
~850
Placebo tablet to match 75 mg linzagolix tablet
2019
Completed Phase 3
~850
Placebo tablet to match 200 mg linzagolix tablet
2019
Completed Phase 3
~850
200 mg linzagolix tablet
2019
Completed Phase 3
~850
Add-back capsule (E2 1 mg / NETA 0.5 mg)
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
58 Previous Clinical Trials
7,063 Total Patients Enrolled
7 Trials studying Endometriosis
741 Patients Enrolled for Endometriosis
LecomteStudy DirectorObsEva SA
2 Previous Clinical Trials
571 Total Patients Enrolled
2 Trials studying Endometriosis
571 Patients Enrolled for Endometriosis
~62 spots leftby Dec 2025
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