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

Recruiting in Palo Alto (17 mi)

+70 other locations

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ObsEva SA

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lecomte

Principal Investigator

ObsEva SA

Eligibility Criteria

Inclusion Criteria

The study found that moderate to severe endometriosis-associated pain during the screening period was common.

Having regular menstrual cycles means that a woman's period comes every 28 days or so.

A person's BMI was ≥ 18 kg/m2 at the screening visit.

Treatment Details

Interventions

• Add-back hormone replacement therapy (Hormone Therapy)
• Linzagolix (Gonadotropin-releasing hormone (GnRH) antagonist)

Participant Groups

Group I: Linzagolix 75 mg Experimental Treatment 3 Interventions

Group II: Linzagolix 200 mg + Add-back (E2 1 mg / NETA 0.5 mg) Experimental Treatment 3 Interventions

Group III: Placebo Placebo Group 3 Interventions

Who Is Running the Clinical Trial?

ObsEva SA

Lead Sponsor

Trials

14

Recruited

4,400+

Kissei Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

62

Recruited

8,000+