TrialScout

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

Female
Age
18+
Phase 3

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



ClinicalTrials.gov 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

Keywords

Hemorrhage
Leiomyoma
Menorrhagia
Myofibroma

Intervention/Treatment

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

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.

You may be eligible to join if...


key

- 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

You may NOT be eligible to join if...



- 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.

Learn About Clinical Trials

blog-img

Your Clinical Trial Journey: Understanding the Clinical Trial Landscape

As you embark on your clinical trial journey, you may be asking: What happens before the drug gets tested in humans? What is a clinical trial? How come some clinical trials have few participants and some have hundreds or...

Read More

AMY ROCHFORD - DEC 27, 2018

blog-img

Clinical Trials Consist of Four Phases: What are they?

Clinical trials is a term that many people have heard, but not enough seem to know about. Conducted to collect data about the efficiency and safety of a potential new treatment option, clinical trials are multi-level processes...

Read More

CLINICAL TRIALS - NOV 20, 2018

blog-img

The Importance of Volunteering in a Clinical Trial

I have always been someone that loves to volunteer and help the local community. I have participated in food drives, given back to the local animal shelter and volunteered at my local ambulance corp. Volunteers are apart of our everyday life, but they seem to be somewhat easily forgotten about. Think about it. You don’t often think about an EMT or volunteer firefighter...

Read More

FRANCESCA DOMINIANNI - JUNE 5, 2019

blog-img

Amazon, Uber, Yelp...Why Not Clinical Trials?

So you call an Uber, you see your driver has a low rating, do you really want to get in the car or are you now feeling skeptical? Or picture this- you are going on a weekend trip with your friends you haven’t seen in years and you want to pick the best restaurants in the area...

Read More

FRANCESCA DOMINIANNI - APR 19, 2019

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 ClinicalTrials.gov >