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



Status:Recruiting
Conditions:Cervical Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/9/2018
Start Date:May 23, 2017
End Date:November 2019
Contact:Chief Medical Officer
Email:clinicaltrials@obseva.ch
Phone:+41225523840

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A Phase 3, Multicentre, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of OBE2109 Alone and in Combination With Add-back Therapy for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

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.

The study is a prospective, randomized, parallel group, double-blind, placebo-controlled
phase 3 study investigating the efficacy and safety of OBE2109 alone and in combination with
add-back therapy for the treatment of uterine fibroids.

Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.

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.
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