Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Completed · Phase 3 · Has a placebo group

Conditions studied: Metrorrhagia

In brief

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

Key facts

Study ID

NCT00293059

Run by

Bayer

People needed

190

Starts

2005-12-01

Expected to finish

2008-05-01

Last updated by the study team

2013-11-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Women and Child, LPP — Lake Havasu City, Arizona, United States
• Marin Endocrine Associates — Greenbrae, California, United States
• Impact Clinical Trials - Los Angeles — Los Angeles, California, United States
• Blue Hill Medical Group — Pacific Palisades, California, United States
• Genesis Center for Clinical Research — San Diego, California, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Women's Health Care, Inc. — San Diego, California, United States
• Clinical Trial Center of Colorado — Greenwood Village, Colorado, United States
• Clinical Trial Center of Colorado — Littleton, Colorado, United States
• South Florida Medical Research — Aventura, Florida, United States
• Women's Medical Research Group, LLC — Clearwater, Florida, United States
• Clinical Physiology Associates, Inc. — Fort Myers, Florida, United States
• New Age Medical Research Corp. — Miami, Florida, United States
• Insignia Care for Women, P.A. — Tampa, Florida, United States
• Mount Vernon Clinical Research — Atlanta, Georgia, United States
• Atlanta West Women's Center — Douglasville, Georgia, United States
• Women's Health Practice — Champaign, Illinois, United States
• Physicians Research Group — Indianapolis, Indiana, United States
• Advanced Biomedical Research of America — Las Vegas, Nevada, United States
• NYU Langone Medical Center — New York, New York, United States
• Eastern Carolina Women's Center — New Bern, North Carolina, United States
• Hawthorne Medical Research, Inc. — Winston-Salem, North Carolina, United States
• Womens Medical Center — Bismarck, North Dakota, United States
• Reproductive Medical Research — Cincinnati, Ohio, United States
• Rapid Medical Research Inc. — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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