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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Fibrocystic Disease of Breast

Intervention / Treatment
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* Drug: danazol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: danazol<br>* danazol applied topically once per day for 4 treatment cycles<br>|
| Active Comparator: 2<br> | Drug: danazol<br>* danazol applied topically once per day for 4 treatment cycles<br>|
| Active Comparator: 3<br> | Drug: danazol<br>* danazol applied topically once per day for 4 treatment cycles<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* placebo topically applied once daily for 4 treatment cycles<br>|
| Placebo Comparator: 5<br> | Drug: Placebo<br>* placebo topically applied once daily for 4 treatment cycles<br>|
| Placebo Comparator: 6<br> | Drug: Placebo<br>* placebo topically applied once daily for 4 treatment cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject reported breast pain as measured using a visual analog scale on the subject daily diary |  | 2 cycles pretreatment plus 4 cycles on treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician assessment of breast nodularity at each treatment cycle visit |  | 2 cycles pretreatment plus 4 cycles on treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibrocystic breast disease, fibrocystic disease of breast, breast pain, mastalgia, cyclic mastalgia, cystic breast disease