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Gonadotropin-releasing hormone (GnRH) antagonist

200 mg linzagolix tablet 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the preceding 4-week period at month 6
Awards & highlights

Study Summary

This study is evaluating whether a drug may help treat endometriosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the preceding 4-week period at month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the preceding 4-week period at month 6 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

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Linzagolix 75 mgExperimental Treatment3 Interventions
Group II: Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg)Experimental Treatment3 Interventions
Group III: PlaceboPlacebo Group3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Add-back capsule (E2 1 mg / NETA 0.5 mg)
2019
Completed Phase 3
~850
75 mg linzagolix tablet
2019
Completed Phase 3
~850
200 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
Placebo capsule to match Add-back capsule
2019
Completed Phase 3
~850

Find a Location

Who is running the clinical trial?

ObsEva SALead Sponsor
13 Previous Clinical Trials
3,895 Total Patients Enrolled
4 Trials studying Endometriosis
799 Patients Enrolled for Endometriosis
Kissei Pharmaceutical Co., Ltd.Lead Sponsor
56 Previous Clinical Trials
6,688 Total Patients Enrolled
6 Trials studying Endometriosis
526 Patients Enrolled for Endometriosis
LecomteStudy DirectorObsEva SA
2 Previous Clinical Trials
441 Total Patients Enrolled
2 Trials studying Endometriosis
441 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.

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Affinity Clinical Research Institute/ ID # 622
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.
2019. "Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03992846.
~83 spots leftby Apr 2025
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