Trial Scout

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

Study Location

OBGYN Associates of WNY

ClinicalTrials.gov Identifier: NCT03070951
Recruitment Status: Recruiting
First Posted: 3/6/2017 12:00:00 AM
Last Update Posted: 12/7/2018 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

Hemorrhage
Leiomyoma
Menorrhagia
Myofibroma

Intervention/Treatment

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

Phase

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.

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