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

FemmePharma Global Healthcare, Inc.60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Fibrocystic Disease of Breast

Interventions

danazolDRUG

danazol applied topically once per day for 4 treatment cycles

PlaceboDRUG

placebo topically applied once daily for 4 treatment cycles

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (30)

Outcomes

Primary Outcomes

Subject reported breast pain as measured using a visual analog scale on the subject daily diary

Time frame: 2 cycles pretreatment plus 4 cycles on treatment

Secondary Outcomes

Physician assessment of breast nodularity at each treatment cycle visit

Time frame: 2 cycles pretreatment plus 4 cycles on treatment

Data from ClinicalTrials.gov

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