Trials / Completed
CompletedNCT00744276
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- FemmePharma Global Healthcare, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | danazol | danazol applied topically once per day for 4 treatment cycles |
| DRUG | Placebo | placebo topically applied once daily for 4 treatment cycles |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2009-04-01
- Completion
- 2009-06-01
- First posted
- 2008-08-29
- Last updated
- 2010-05-27
Locations
30 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00744276. Inclusion in this directory is not an endorsement.