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OpenTrials
Completed

NCT Number: NCT00744276

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

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.

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Key information

Conditions

Fibrocystic Disease of Breast Breast Diseases Fibrocystic Breast Disease Mastodynia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Women's Health Research, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danazol

Drug

danazol applied topically once per day for 4 treatment cycles

Placebo

Drug

placebo topically applied once daily for 4 treatment cycles

Primary outcomes

  1. 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

  1. Physician assessment of breast nodularity at each treatment cycle visit

    Time frame: 2 cycles pretreatment plus 4 cycles on treatment

Sponsors and collaborators

Lead sponsor

FemmePharma Global Healthcare, Inc.

Industry

Registry information

Official study title

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

Acronym: FP1198-001

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 29, 2008
Registry last updated
May 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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