A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease
- Registration Number
- NCT00744276
- Lead Sponsor
- FemmePharma Global Healthcare, Inc.
- 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 the appropriate clinical dose for future studies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6 Placebo - 5 Placebo - 4 Placebo - 1 danazol - 2 danazol - 3 danazol -
- Primary Outcome Measures
Name Time Method Subject reported breast pain as measured using a visual analog scale on the subject daily diary 2 cycles pretreatment plus 4 cycles on treatment
- Secondary Outcome Measures
Name Time Method Physician assessment of breast nodularity at each treatment cycle visit 2 cycles pretreatment plus 4 cycles on treatment
Trial Locations
- Locations (29)
Women's Health Research
🇺🇸Phoenix, Arizona, United States
Advanced Clinical Therapeutics, LLC
🇺🇸Tucson, Arizona, United States
Impact Clinical Trials
🇺🇸Las Vegas, Nevada, 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, 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
Scroll for more (19 remaining)Women's Health Research🇺🇸Phoenix, Arizona, United States