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

Recruiting at 70 trial locations

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: ObsEva SA

Must be taking: Add-back therapy

Must not be taking: GnRH agonists

Disqualifiers: Pregnancy, Osteoporosis, Chronic pelvic pain, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

486 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic pain medication for conditions other than endometriosis, it might interfere with the study.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive linzagolix or placebo orally once daily for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Extension

Eligible participants may enter a separate extension study for 6 additional months of active treatment

6 months

Treatment Details

Interventions

• Add-back hormone replacement therapy
• Linzagolix

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+