Overview

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.