Status:
COMPLETED
A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease
Lead Sponsor:
FemmePharma Global Healthcare, Inc.
Conditions:
Fibrocystic Disease of Breast
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00744276
Start Date
January 1 2007
End Date
June 1 2009
Last Update
May 27 2010
Active Locations (30)
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1
Women's Health Research
Phoenix, Arizona, United States, 85015
2
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, United States, 85712
3
Impact Clinical Trials
Beverly Hills, California, United States, 90211
4
Women's Health Care at Frost Street
San Diego, California, United States, 92123