Trial Scout

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

Health System

OBGYN Associates of WNY Identifier: NCT03070951
Recruitment Status: Active, not recruiting
First Posted: 3/6/2017 12:00:00 AM
Last Update Posted: 4/29/2019 12:00:00 AM

Study Description

Eligibility Criteria

Additional Contacts

Brief Summary

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

Condition or Disease



Drug: Placebo + Placebo Add-back / Placebo tablets and Placebo Add-back for oral administration once daily


Phase 3

Detailed Description

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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Go to >