Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

• Status: Completed
• Trial end date: 2020-10-04
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ObsEva SA
• Treatments: OBE2109

Criteria

Key Inclusion Criteria:

• Premenopausal woman at screening.

• Body Mass Index ≥ 18 kg/m2.

• Menstrual cycles ≥ 21 days and ≤ 40 days.

• Presence of uterine fibroids.

• Heavy menstrual blood loss for each of the 2 menstrual periods assessed at screening using the alkaline hematin method.

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.

• History of uterus surgery that would interfere with the study.

• The subject's condition is so severe that she will require surgery within 6 months regardless of the treatment provided.

• Undiagnosed abnormal uterine bleeding.

• Significant risk of osteoporosis or history of, or known osteoporosis or other metabolic bone disease.