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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FemmePharma Global Healthcare, Inc.
• Treatments: Danazol

Criteria

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