A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease (FP1198-001)

FemmePharma

Status and phase: Completed; Phase 2

Conditions: Fibrocystic Disease of Breast

Treatments: Drug: danazol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00744276

FP1198-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 6 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: danazol

2

Active Comparator group

Treatment:

Drug: danazol

3

Active Comparator group

Treatment:

Drug: danazol

4

Placebo Comparator group

Treatment:

Drug: Placebo

5

Placebo Comparator group

Treatment:

Drug: Placebo

6

Placebo Comparator group

Treatment:

Drug: Placebo