A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Fibrocystic Disease of Breast

In brief

The purpose of this study is to determine the safety of three doses of topically applied danazol compared to placebo in subjects with pain associated with fibrocystic breast disease and to determine the appropriate clinical dose for future studies.

Key facts

Study ID

NCT00744276

Run by

FemmePharma Global Healthcare, Inc.

People needed

60

Starts

2007-01-01

Expected to finish

2009-06-01

Last updated by the study team

2010-05-27

Who can join

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

You may qualify if…

• Menstruating females at least 18 years of age
• Has moderate to severe breast pain associated with cyclical fibrocystic breast disease
• Is in good general health

You may not qualify if…

• Pregnant within the past 6 months or lactating
• History of malignancy or currently being treated for cancer of the breast or genital organs
• Has taken within the past 3 months or is currently taking hormonal contraception
• Has any condition for which an androgen or steroid is contraindicated
• Has had breast implants or breast reduction surgery

Where it is running

• Women's Health Research — Phoenix, Arizona, United States
• Advanced Clinical Therapeutics, LLC — Tucson, Arizona, United States
• Impact Clinical Trials — Beverly Hills, California, United States
• Women's Health Care at Frost Street — San Diego, California, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• James A Simon, M.D., PC — Washington D.C., District of Columbia, United States
• Visions Clinical Research — Boynton Beach, Florida, United States
• Southeastern Integrated Medical, LLC — Gainsville, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Atlanta North Gynecology, PC — Roswell, Georgia, United States
• Women's Health Practice — Champaign, Illinois, United States
• Center for Women's Research — Chicago, Illinois, United States
• Physician's Research Group — Indianapolis, Indiana, United States
• Kentucky Medical Research Center — Lexington, Kentucky, United States
• MedVadis Research Corporation — Wellesley Hills, Massachusetts, United States
• Impact Clinical Trials — Las Vegas, Nevada, United States
• Delaware Valley OB/GYN and Infertility Group, PC — Lawrenceville, New Jersey, United States
• Phoenix OB-GYN Associates — Moorestown, New Jersey, United States
• UMDNJ Robert Wood Johnson Medica School Women's Health Institute — New Brunswick, New Jersey, United States
• Analgesic Development, Ltd. — New York, New York, United States
• Rochester Clinical Research, Inc. — Rochester, New York, United States
• Columbus Center for Women's Health Research — Columbus, Ohio, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Southeastern Clinical Research — Chattanooga, Tennessee, United States
• Jackson Clinic — Jackson, Tennessee, United States

Full record on ClinicalTrials.gov

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