Clinical trial NCT00744276: A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibrocystic Disease of Breast
Keywords: fibrocystic breast disease
fibrocystic disease of breast
breast pain
mastalgia
cyclic mastalgia
cystic breast disease
Lead sponsor: FemmePharma Global Healthcare, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Subject reported breast pain as measured using a visual analog scale on the subject daily diary
timeFrame: 2 cycles pretreatment plus 4 cycles on treatment
Secondary outcomes:
measure: Physician assessment of breast nodularity at each treatment cycle visit
timeFrame: 2 cycles pretreatment plus 4 cycles on treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics, LLC
state: Arizona
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: San Diego
country: United States
facility: Women's Health Care at Frost Street
state: California
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Washington
country: United States
facility: James A Simon, M.D., PC
state: District of Columbia
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Gainsville
country: United States
facility: Southeastern Integrated Medical, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Roswell
country: United States
facility: Atlanta North Gynecology, PC
state: Georgia
city: Champaign
country: United States
facility: Women's Health Practice
state: Illinois
city: Chicago
country: United States
facility: Center for Women's Research
state: Illinois
city: Indianapolis
country: United States
facility: Physician's Research Group
state: Indiana
city: Lexington
country: United States
facility: Kentucky Medical Research Center
state: Kentucky
city: Wellesley Hills
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Las Vegas
country: United States
facility: Impact Clinical Trials
state: Nevada
city: Lawrenceville
country: United States
facility: Delaware Valley OB/GYN and Infertility Group, PC
state: New Jersey
city: Moorestown
country: United States
facility: Phoenix OB-GYN Associates
state: New Jersey
city: New Brunswick
country: United States
facility: UMDNJ Robert Wood Johnson Medica School Women's Health Institute
state: New Jersey
city: New York
country: United States
facility: Analgesic Development, Ltd.
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Columbus
country: United States
facility: Columbus Center for Women's Health Research
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Chattanooga
country: United States
facility: Southeastern Clinical Research
state: Tennessee
city: Jackson
country: United States
facility: Jackson Clinic
state: Tennessee
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Seven Oaks Women's Center
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Richmond
country: United States
facility: Virginia Women's Center
state: Virginia
city: Seattle
country: United States
facility: Women's Clinical Research Center
state: Washington
Study officials:
affiliation: FemmePharma Global Healthcare, Inc.
name: Peter K. Mays, Ph.D.
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/s0140-6736(87)91204-9.
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. doi: 10.1136/bmj.295.6596.464.
citation: Gateley CA, Mansel RE. Management of cyclical breast pain. Br J Hosp Med. 1990 May;43(5):330-2.
citation: Barbieri RL. Danazol: molecular, endocrine, and clinical pharmacology. Prog Clin Biol Res. 1990;323:241-52. No abstract available.
citation: Gumm R, Cunnick GH, Mokbel K. Evidence for the management of mastalgia. Curr Med Res Opin. 2004 May;20(5):681-4. doi: 10.1185/030079904125003377.
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. doi: 10.3949/ccjm.69.5.425.
citation: Sitruk-Ware R, Sterkers N, Mauvais-Jarvis P. Benign breast disease I: hormonal investigation. Obstet Gynecol. 1979 Apr;53(4):457-60.
citation: Wang DY, Fentiman IS. Epidemiology and endocrinology of benign breast disease. Breast Cancer Res Treat. 1985;6(1):5-36. doi: 10.1007/BF01806008.
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. doi: 10.1016/0960-0760(92)90163-d.