Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Last updated: November 5, 2013
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

Dysfunctional Uterine Bleeding

Uterine Disorders

Female Hormonal Deficiencies/abnormalities

Treatment

N/A

Clinical Study ID

NCT00293059
91469
308960
  • Ages > 18
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 excessivebleeding

Exclusion

Exclusion Criteria:

  • The use of steroidal oral contraceptives, or any drug that could alter oralcontraception metabolism will be prohibited during the study.

  • Women with history of endometrial ablation or dilatation or curettage within 2 monthsprior to study start will be excluded.

Study Design

Total Participants: 190
Study Start date:
December 01, 2005
Estimated Completion Date:
May 31, 2008

Study 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.

Connect with a study center

  • Maritimes Research Center

    Bathurst, New Brunswick E2A 4X7
    Canada

    Site Not Available

  • Total Concept Health Care Inc.

    Kitchener, Ontario N2C 2N9
    Canada

    Site Not Available

  • Prime Health Research

    Toronto, Ontario M4S 1Y2
    Canada

    Site Not Available

  • Centre d'étude clinique de Montréal Inc.

    Montreal, Quebec H1T 1P6
    Canada

    Site Not Available

  • Les Gynecologues Associes

    Montreal, Quebec H2X 1N8
    Canada

    Site Not Available

  • Clinique de Gynecologie

    Shawinigan, Quebec G9N 2H6
    Canada

    Site Not Available

  • Q & T Research, Inc.

    Sherbrooke, Quebec J1H 4J6
    Canada

    Site Not Available

  • Clinique Médicale des Campus

    Ste-Foy, Quebec G1V 4X7
    Canada

    Site Not Available

  • Clinique Recherche en Sante des Femmes Inc.

    Quebec, G1S 2L6
    Canada

    Site Not Available

  • Women and Child, LPP

    Lake Havasu CIty, Arizona 86403
    United States

    Site Not Available

  • Marin Endocrine Associates

    Greenbrae, California 94904
    United States

    Site Not Available

  • Impact Clinical Trials - Los Angeles

    Los Angeles, California 90010
    United States

    Site Not Available

  • Blue Hill Medical Group

    Pacific Palisades, California 90272
    United States

    Site Not Available

  • Genesis Center for Clinical Research

    San Diego, California 92103
    United States

    Site Not Available

  • Medical Center for Clinical Research

    San Diego, California 92108
    United States

    Site Not Available

  • Women's Health Care, Inc.

    San Diego, California 92123
    United States

    Site Not Available

  • Clinical Trial Center of Colorado

    Greenwood Village, Colorado 80111
    United States

    Site Not Available

  • Clinical Trial Center of Colorado

    Littleton, Colorado 80122
    United States

    Site Not Available

  • South Florida Medical Research

    Aventura, Florida 33180
    United States

    Site Not Available

  • Women's Medical Research Group, LLC

    Clearwater, Florida 33759
    United States

    Site Not Available

  • Clinical Physiology Associates, Inc.

    Fort Myers, Florida 33916
    United States

    Site Not Available

  • Clinical Physiology Associates, Inc.

    Ft. Myers, Florida 33916
    United States

    Site Not Available

  • New Age Medical Research Corp.

    Miami, Florida 33186
    United States

    Site Not Available

  • Insignia Care for Women, P.A.

    Tampa, Florida 33607
    United States

    Site Not Available

  • Mount Vernon Clinical Research

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Atlanta West Women's Center

    Douglasville, Georgia 30134
    United States

    Site Not Available

  • Women's Health Practice

    Champaign, Illinois 61820
    United States

    Site Not Available

  • Physicians Research Group

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Advanced Biomedical Research of America

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • Eastern Carolina Women's Center

    New Bern, North Carolina 28562
    United States

    Site Not Available

  • Hawthorne Medical Research, Inc.

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Womens Medical Center

    Bismark, North Dakota 58501
    United States

    Site Not Available

  • Reproductive Medical Research

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Rapid Medical Research Inc.

    Cleveland, Ohio 44122
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania 19114
    United States

    Site Not Available

  • Women's Health Care Group of PA

    Pottstown, Pennsylvania 19464
    United States

    Site Not Available

  • South Carolina Clinical Research Center

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • Brown Clinic, P.L.L.P.

    Watertown, South Dakota 57201
    United States

    Site Not Available

  • New South Medical

    Clarksville, Tennessee 37043
    United States

    Site Not Available

  • Advanced Research Associates

    Corpus Christi, Texas 78414
    United States

    Site Not Available

  • Obstetrical & Gynecological Associates, PA

    Houston, Texas
    United States

    Site Not Available

  • Research Across America

    Plano, Texas 75093
    United States

    Site Not Available

  • National Clinical Research, Inc.

    Richmond, Virginia 23294
    United States

    Site Not Available

  • North Spokane Women's Clinic

    Spokane, Washington 99207
    United States

    Site Not Available

  • Dr. John Lenihan, MD

    Tacoma, Washington 98405
    United States

    Site Not Available

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