Trial Condition(s):

Metrorrhagia

Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Bayer Identifier:

91469

ClinicalTrials.gov Identifier:

NCT00293059

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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 excessive bleeding
Exclusion Criteria
- 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.

Trial Summary

Enrollment Goal
190
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Marin Endocrine Associates

Greenbrae, United States, 94904

Status
Completed
 
Locations

Women's Health Care, Inc.

San Diego, United States, 92123

Status
Completed
 
Locations

Genesis Center for Clinical Research

San Diego, United States, 92103

Status
Completed
 
Locations

Clinical Trial Center of Colorado

Greenwood Village, United States, 80111

Status
Completed
 
Locations

Brown Clinic, P.L.L.P.

Watertown, United States, 57201

Status
Completed
 
Locations

Hawthorne Medical Research, Inc.

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Oregon Health and Science University

Portland, United States, 97239

Status
Completed
 
Locations

Women and Child, LPP

Lake Havasu CIty, United States, 86403

Status
Completed
 
Locations

New South Medical

Clarksville, United States, 37043

Status
Completed
 
Locations

South Carolina Clinical Research Center

Columbia, United States, 29201

Status
Completed
 
Locations

Rapid Medical Research Inc.

Cleveland, United States, 44122

Status
Completed
 
Locations

Clinical Physiology Associates, Inc.

Fort Myers, United States, 33916

Status
Completed
 
Locations

NYU Langone Medical Center

New York, United States, 10016

Status
Completed
 
Locations

Women's Medical Research Group, LLC

Clearwater, United States, 33759

Status
Completed
 
Locations

Women's Health Practice

Champaign, United States, 61820

Status
Completed
 
Locations

Clinique de Gynecologie

Shawinigan, Canada, G9N 2H6

Status
Completed
 
Locations

Les Gynecologues Associes

Montreal, Canada, H2X 1N8

Status
Completed
 
Locations

Centre d'étude clinique de Montréal Inc.

Montreal, Canada, H1T 1P6

Status
Completed
 
Locations

Maritimes Research Center

Bathurst, Canada, E2A 4X7

Status
Completed
 
Locations

National Clinical Research, Inc.

Richmond, United States, 23294

Status
Completed
 
Locations

Advanced Research Associates

Corpus Christi, United States, 78414

Status
Completed
 
Locations

Research Across America

Plano, United States, 75093

Status
Completed
 
Locations

New Age Medical Research Corp.

Miami, United States, 33186

Status
Completed
 
Locations

South Florida Medical Research

Aventura, United States, 33180

Status
Completed
 
Locations

Impact Clinical Trials - Los Angeles

Los Angeles, United States, 90010

Status
Completed
 
Locations

Physicians Research Group

Indianapolis, United States, 46250

Status
Completed
 
Locations

Advanced Biomedical Research of America

Las Vegas, United States, 89119

Status
Completed
 
Locations

Medical Center for Clinical Research

San Diego, United States, 92108

Status
Completed
 
Locations

Dr. John Lenihan, MD

Tacoma, United States, 98405

Status
Completed
 
Locations

North Spokane Women's Clinic

Spokane, United States, 99207

Status
Completed
 
Locations

Eastern Carolina Women's Center

New Bern, United States, 28562

Status
Completed
 
Locations

Blue Hill Medical Group

Pacific Palisades, United States, 90272

Status
Completed
 
Locations

Clinical Research of Philadelphia, LLC

Philadelphia, United States, 19114

Status
Completed
 
Locations

Reproductive Medical Research

Cincinnati, United States, 45267

Status
Completed
 
Locations

Insignia Care for Women, P.A.

Tampa, United States, 33607

Status
Completed
 
Locations

Clinical Trial Center of Colorado

Littleton, United States, 80122

Status
Completed
 
Locations

Womens Medical Center

Bismark, United States, 58501

Status
Completed
 
Locations

Obstetrical & Gynecological Associates, PA

Houston, United States

Status
Completed
 
Locations

Women's Health Care Group of PA

Pottstown, United States, 19464

Status
Completed
 
Locations

Mount Vernon Clinical Research

Atlanta, United States, 30328

Status
Completed
 
Locations

Atlanta West Women's Center

Douglasville, United States, 30134

Status
Completed
 
Locations

Clinique Médicale des Campus

Ste-Foy, Canada, G1V 4X7

Status
Completed
 
Locations

Clinique Recherche en Sante des Femmes Inc.

Quebec, Canada, G1S 2L6

Status
Completed
 
Locations

Total Concept Health Care Inc.

Kitchener, Canada, N2C 2N9

Status
Completed
 
Locations

Q & T Research, Inc.

Sherbrooke, Canada, J1H 4J6

Status
Completed
 
Locations

Prime Health Research

Toronto, Canada, M4S 1Y2

Status
Completed
 

Trial Design