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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00744276

Acronym

FP1198-001

Enrollment

Registered

2008-08-29

Start date

2007-01-31

Completion date

2009-06-30

Last updated

2010-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrocystic Disease of Breast

Keywords

fibrocystic breast disease, fibrocystic disease of breast, breast pain, mastalgia, cyclic mastalgia, cystic breast disease

Brief 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.

Interventions

DRUGdanazol

danazol applied topically once per day for 4 treatment cycles

DRUGPlacebo

placebo topically applied once daily for 4 treatment cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Physician assessment of breast nodularity at each treatment cycle visit	2 cycles pretreatment plus 4 cycles on treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026