Title
A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Multicenter Evaluation of the Use of Topically Administered Danazol Versus Placebo in Subjects With Pain Associated With Fibrocystic Breast Disease
Phase
Phase 2Lead Sponsor
FemmePharma Global Healthcare, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Fibrocystic Disease of BreastIntervention/Treatment
danazol ...Study Participants
60The 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.
danazol applied topically once per day for 4 treatment cycles
placebo topically applied once daily for 4 treatment cycles
Inclusion Criteria: 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 Criteria: 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