A phase 3 study to confirm the efficacy and safety of linzagolix to treat endometriosis-associated pain.

Phase 1

• Conditions: Endometriosis-associated pain; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]; MedDRA version: 20.0Level: PTClassification code 10014778Term: EndometriosisSystem Organ Class: 10038604 - Reproductive system and breast disorders

• Registration Number: EUCTR2019-000283-26-RO
• Lead Sponsor: ObsEva S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-24
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

1. The subject must have had her most recent surgical and – if available – histological diagnosis of pelvic endometriosis (laparoscopy, laparotomy, vaginal fornix or other biopsy) up to 10 years before screening.
2. The subject has moderate to severe endometriosis- associated pain during the screening period.
3. The subject has regular menstrual cycles.
4. The subject has a Body BMI = 18 kg/m2 at the screening visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.
2. The subject is less than 6 months postpartum or 3 months post-abortion/miscarriage at the time of entry into the screening period.
3. The subject has a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening.
4. The subject did not respond to prior treatment with GnRH agonists or GnRH antagonists for endometriosis.
5. The subject has a history of, or known, osteoporosis or other metabolic bone disease.
6. The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified