A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to assess the efficacy and safety of a range of oral doses of OBE2109 versus placebo, in reducing endometriosis associated pain.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ObsEva SA
• Treatments: OBE2109

Criteria

Key Inclusion Criteria:

• The subject must have had her most recent surgical and - if available - histological, diagnosis of pelvic endometriosis up to 10 years before screening.

• The subject has moderate to severe endometriosis-associated pain during the screening period.

• The subject has regular menstrual cycles.

• The subject has a BMI ≥ 18 kg/m2 at the screening visit.

Key Exclusion Criteria:

• The subject is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study.

• The subject had an interventional surgery for endometriosis performed within a period of 60 days before screening.

• The subject did not respond to prior treatment with gonadotropin releasing hormone (GnRH) agonists or GnRH antagonists for endometriosis.

• The subject has a history of, or known osteoporosis or other metabolic bone disease.

• The subject has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic / therapy, or that would interfere with the assessment of endometriosis related pain.