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Gonadotropin-releasing hormone (GnRH) antagonist

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

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
Pivotal Trial

Summary

This trial is testing a new pill called linzagolix, either alone or with a small dose of hormone therapy, to help women with moderate to severe endometriosis pain. The pill aims to reduce pain by lowering specific hormones that contribute to the symptoms. Linzagolix is developed for treating uterine fibroids and endometriosis.

Eligible Conditions
  • 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction of Dysmenorrhea (DYS) at Month 3 - Proportion of Responders
Reduction of Non-menstrual Pelvic Pain (NMPP) at Month 3 - Proportion of Responders
Secondary study objectives
Dyschezia
Dysmenorrhea
Dyspareunia
+5 more

Side effects data

From 2022 Phase 3 trial • 356 Patients • NCT04335591
6%
Anaemia
5%
COVID-19
4%
Headache
3%
Hot flush
3%
Vaginal haemorrhage
1%
Anxiety
1%
Cholelithiasis
1%
Vulvovaginal mycotic infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo/LGX 200 mg+ABT
LGX 75 mg
LGX 200 mg+ABT
Placebo/LGX 75 mg

Awards & Highlights

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

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
59 Previous Clinical Trials
7,083 Total Patients Enrolled
7 Trials studying Endometriosis
611 Patients Enrolled for Endometriosis
LecomteStudy DirectorObsEva SA
2 Previous Clinical Trials
441 Total Patients Enrolled
2 Trials studying Endometriosis
441 Patients Enrolled for Endometriosis
~75 spots leftby Dec 2025
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