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

Fibrocystic Disease of Breast Clinical Trial

— FP1198-001  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744276
• Other study ID #: FP1198-001
• Status: Completed
• Phase: Phase 2
• First received: August 28, 2008
• Last updated: May 25, 2010
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: May 2010
• Source: FemmePharma Global Healthcare, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Diseases
• Cystic Fibrosis
• Fibrocystic Disease of Breast

Intervention

Drug:
• danazol
danazol applied topically once per day for 4 treatment cycles
• Placebo
placebo topically applied once daily for 4 treatment cycles

Locations

Country	Name	City	State
United States	Impact Clinical Trials	Beverly Hills	California
United States	Visions Clinical Research	Boynton Beach	Florida
United States	Women's Health Practice	Champaign	Illinois
United States	Southeastern Clinical Research	Chattanooga	Tennessee
United States	Center for Women's Research	Chicago	Illinois
United States	Columbus Center for Women's Health Research	Columbus	Ohio
United States	Horizons Clinical Research Center, LLC	Denver	Colorado
United States	Southeastern Integrated Medical, LLC	Gainsville	Florida
United States	Physician's Research Group	Indianapolis	Indiana
United States	Jackson Clinic	Jackson	Tennessee
United States	Impact Clinical Trials	Las Vegas	Nevada
United States	Delaware Valley OB/GYN and Infertility Group, PC	Lawrenceville	New Jersey
United States	Kentucky Medical Research Center	Lexington	Kentucky
United States	Phoenix OB-GYN Associates	Moorestown	New Jersey
United States	UMDNJ Robert Wood Johnson Medica School Women's Health Institute	New Brunswick	New Jersey
United States	Analgesic Development, Ltd.	New York	New York
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Women's Health Research	Phoenix	Arizona
United States	Virginia Women's Center	Richmond	Virginia
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Atlanta North Gynecology, PC	Roswell	Georgia
United States	Salt Lake Research	Salt Lake City	Utah
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Seven Oaks Women's Center	San Antonio	Texas
United States	Women's Health Care at Frost Street	San Diego	California
United States	Women's Clinical Research Center	Seattle	Washington
United States	Advanced Clinical Therapeutics, LLC	Tucson	Arizona
United States	James A Simon, M.D., PC	Washington	District of Columbia
United States	MedVadis Research Corporation	Wellesley Hills	Massachusetts
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
FemmePharma Global Healthcare, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

Barbieri RL. Danazol: molecular, endocrine, and clinical pharmacology. Prog Clin Biol Res. 1990;323:241-52. Review. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject reported breast pain as measured using a visual analog scale on the subject daily diary		2 cycles pretreatment plus 4 cycles on treatment	No
Secondary	Physician assessment of breast nodularity at each treatment cycle visit		2 cycles pretreatment plus 4 cycles on treatment	No

External Links

•   General breast health information