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 II

Genetics Home Reference related topics:

cystic fibrosis

MedlinePlus related topics:

Breast Diseases Cystic Fibrosis

Drug Information available for:

Danazol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

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
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: danazol danazol applied topically once per day for 4 treatment cycles
2: Active Comparator	Drug: danazol danazol applied topically once per day for 4 treatment cycles
3: Active Comparator	Drug: danazol danazol applied topically once per day for 4 treatment cycles
4: Placebo Comparator	Drug: Placebo placebo topically applied once daily for 4 treatment cycles
5: Placebo Comparator	Drug: Placebo placebo topically applied once daily for 4 treatment cycles
6: Placebo Comparator	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

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

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:	FemmePharma Global Healthcare, Inc. ( Peter K. Mays, Ph.D. / Vice President, Pharmaceutical Development )
Study ID Numbers:	FP1198-001
First Received:	August 28, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00744276
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

Study placed in the following topic categories:

Fibrocystic Breast Disease

Skin Diseases

Fibrosis

Pain

Digestive System Diseases

Cystic Fibrosis

Respiratory Tract Diseases

Genetic Diseases, Inborn

Danazol

Lung Diseases

Pancreatic Diseases

Infant, Newborn, Diseases

Cystic fibrosis

Breast Diseases

Additional relevant MeSH terms:

Estrogen Receptor Modulators

Estrogen Antagonists

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	FemmePharma Global Healthcare, Inc.
Information provided by:	FemmePharma Global Healthcare, Inc.
ClinicalTrials.gov Identifier:	NCT00744276