At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 target
Drug / intervention
danazol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating danazol and Placebo for Fibrocystic Disease of Breast. Completed, enrolled 60 participants across 30 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibrocystic Disease of Breast
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedAug 2008
Primary CompletionApr 2009
Study CompletionJun 2009
TodayJul 2026
First PostedAug 29, 2008
Enrollment StartJan 1, 2007
Primary CompletionApr 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.8 years ago
Interventions
danazoldrug
danazol applied topically once per day for 4 treatment cycles
Placebodrug
placebo topically applied once daily for 4 treatment cycles