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 2
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    danazol ...
  • Study Participants

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.
Study Started
Jan 31
Primary Completion
Apr 30
Study Completion
Jun 30
Last Update
May 27

Drug danazol

danazol applied topically once per day for 4 treatment cycles

Drug Placebo

placebo topically applied once daily for 4 treatment cycles

1 Active Comparator

2 Active Comparator

3 Active Comparator

4 Placebo Comparator

5 Placebo Comparator

6 Placebo Comparator


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
No Results Posted