Status:

COMPLETED

Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Lead Sponsor:

Bayer

Conditions:

Metrorrhagia

Eligibility:

FEMALE

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

Detailed Description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility Criteria

Inclusion

  • Women 18 years or older
  • With diagnosis of dysfunctional uterine bleeding without organic pathology
  • And with at least one of the following symptoms: prolonged, frequent, or excessive bleeding

Exclusion

  • The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
  • Women with history of endometrial ablation or dilatation or curettage within 2 months prior to study start will be excluded.

Key Trial Info

Start Date :

December 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2008

Estimated Enrollment :

190 Patients enrolled

Trial Details

Trial ID

NCT00293059

Start Date

December 1 2005

End Date

May 1 2008

Last Update

November 27 2013

Active Locations (46)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 12 (46 locations)

1

Women and Child, LPP

Lake Havasu City, Arizona, United States, 86403

2

Marin Endocrine Associates

Greenbrae, California, United States, 94904

3

Impact Clinical Trials - Los Angeles

Los Angeles, California, United States, 90010

4

Blue Hill Medical Group

Pacific Palisades, California, United States, 90272