A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease - Full Text View

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:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Breast Diseases Cystic Fibrosis

Drug Information available for: Danazol

U.S. FDA Resources

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

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

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Locations

United States, Arizona
Women's Health Research
Phoenix, Arizona, United States, 85015
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, United States, 85712
United States, California
Impact Clinical Trials
Beverly Hills, California, United States, 90211
Women's Health Care at Frost Street
San Diego, California, United States, 92123
United States, Colorado
Horizons Clinical Research Center, LLC
Denver, Colorado, United States, 80220
United States, District of Columbia
James A Simon, M.D., PC
Washington, District of Columbia, United States, 20036
United States, Florida
Visions Clinical Research
Boynton Beach, Florida, United States, 33437
Southeastern Integrated Medical, LLC
Gainsville, Florida, United States, 32607
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
Atlanta North Gynecology, PC
Roswell, Georgia, United States, 30075
United States, Illinois
Women's Health Practice
Champaign, Illinois, United States, 61820
Center for Women's Research
Chicago, Illinois, United States, 60612
United States, Indiana
Physician's Research Group
Indianapolis, Indiana, United States, 46250
United States, Kentucky
Kentucky Medical Research Center
Lexington, Kentucky, United States, 40504
United States, Massachusetts
MedVadis Research Corporation
Wellesley Hills, Massachusetts, United States, 02481-2106
United States, Nevada
Impact Clinical Trials
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Delaware Valley OB/GYN and Infertility Group, PC
Lawrenceville, New Jersey, United States, 08648
Phoenix OB-GYN Associates
Moorestown, New Jersey, United States, 08057
UMDNJ Robert Wood Johnson Medica School Women's Health Institute
New Brunswick, New Jersey, United States, 08901
United States, New York
Analgesic Development, Ltd.
New York, New York, United States, 10022-1009
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
United States, Ohio
Columbus Center for Women's Health Research
Columbus, Ohio, United States, 43213
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102-1192
United States, Tennessee
Southeastern Clinical Research
Chattanooga, Tennessee, United States, 37403
Jackson Clinic
Jackson, Tennessee, United States, 38305
United States, Texas
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Seven Oaks Women's Center
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84107
United States, Virginia
Virginia Women's Center
Richmond, Virginia, United States, 23233
United States, Washington
Women's Clinical Research Center
Seattle, Washington, United States, 98105

Sponsors and Collaborators

FemmePharma Global Healthcare, Inc.

Investigators

Study Director:

Peter K. Mays, Ph.D.

FemmePharma Global Healthcare, Inc.

More Information

Additional Information:

General breast health information This link exits the ClinicalTrials.gov site

Publications:

Hughes LE, Mansel RE, Webster DJ. Aberrations of normal development and involution (ANDI): a new perspective on pathogenesis and nomenclature of benign breast disorders. Lancet. 1987 Dec 5;2(8571):1316-9.

Panahy C, Puddefoot JR, Anderson E, Vinson GP, Berry CL, Turner MJ, Brown CL, Goode AW. Effects of danazol on incidence of progesterone and oestrogen receptors in benign breast disease. Br Med J (Clin Res Ed). 1987 Aug 22;295(6596):464-6.

Gateley CA, Mansel RE. Management of cyclical breast pain. Br J Hosp Med. 1990 May;43(5):330-2.

Barbieri RL. Danazol: molecular, endocrine, and clinical pharmacology. Prog Clin Biol Res. 1990;323:241-52. Review. No abstract available.

Gumm R, Cunnick GH, Mokbel K. Evidence for the management of mastalgia. Curr Med Res Opin. 2004 May;20(5):681-4. Review.

Vaidyanathan L, Barnard K, Elnicki DM. Benign breast disease: when to treat, when to reassure, when to refer. Cleve Clin J Med. 2002 May;69(5):425-32.

Sitruk-Ware R, Sterkers N, Mauvais-Jarvis P. Benign breast disease I: hormonal investigation. Obstet Gynecol. 1979 Apr;53(4):457-60.

Wang DY, Fentiman IS. Epidemiology and endocrinology of benign breast disease. Breast Cancer Res Treat. 1985;6(1):5-36. Review.

Gledhill JM, Barker S, Wanless C, Hinson JP, Puddefoot JR, Panahy C, Goode AW, Vinson GP. Progesterone receptor induction by danazol in cultured cancer cells and the rat uterus. J Steroid Biochem Mol Biol. 1992 Oct;43(4):289-96.

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 May 22, 2013

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