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

This study has been completed.
Sponsor:
Information provided by:
FemmePharma Global Healthcare, Inc.
ClinicalTrials.gov Identifier:
NCT00744276
First received: August 28, 2008
Last updated: May 25, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Fibrocystic Disease of Breast
Drug: danazol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by FemmePharma Global Healthcare, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physician assessment of breast nodularity at each treatment cycle visit [ Time Frame: 2 cycles pretreatment plus 4 cycles on treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: danazol
danazol applied topically once per day for 4 treatment cycles
Active Comparator: 2 Drug: danazol
danazol applied topically once per day for 4 treatment cycles
Active Comparator: 3 Drug: danazol
danazol applied topically once per day for 4 treatment cycles
Placebo Comparator: 4 Drug: Placebo
placebo topically applied once daily for 4 treatment cycles
Placebo Comparator: 5 Drug: Placebo
placebo topically applied once daily for 4 treatment cycles
Placebo Comparator: 6 Drug: Placebo
placebo topically applied once daily for 4 treatment cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744276

  Show 30 Study Locations
Sponsors and Collaborators
FemmePharma Global Healthcare, Inc.
Investigators
Study Director: Peter K. Mays, Ph.D. FemmePharma Global Healthcare, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Peter K. Mays, Ph.D. / Vice President, Pharmaceutical Development, FemmePharma Global Healthcare, Inc.
ClinicalTrials.gov Identifier: NCT00744276     History of Changes
Other Study ID Numbers: FP1198-001
Study First Received: August 28, 2008
Last Updated: May 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by FemmePharma Global Healthcare, Inc.:
fibrocystic breast disease
fibrocystic disease of breast
breast pain
mastalgia
cyclic mastalgia
cystic breast disease

Additional relevant MeSH terms:
Breast Diseases
Cystic Fibrosis
Fibrocystic Breast Disease
Skin Diseases
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Danazol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014