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

NCT00744276 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-05-27

No results posted yet for this study

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.

Conditions

  • Fibrocystic Disease of Breast

Interventions

DRUG

danazol

danazol applied topically once per day for 4 treatment cycles

DRUG

Placebo

placebo topically applied once daily for 4 treatment cycles

Sponsors & Collaborators

  • FemmePharma Global Healthcare, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter K. Mays, Ph.D. · FemmePharma Global Healthcare, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-04-30
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00744276 on ClinicalTrials.gov