A Study of Topical Danazol for the Treatment of Pain Associated With Fibrocystic Breast Disease
NCT ID: NCT00744276
Last Updated: 2010-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2007-01-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
danazol
danazol applied topically once per day for 4 treatment cycles
2
danazol
danazol applied topically once per day for 4 treatment cycles
3
danazol
danazol applied topically once per day for 4 treatment cycles
4
Placebo
placebo topically applied once daily for 4 treatment cycles
5
Placebo
placebo topically applied once daily for 4 treatment cycles
6
Placebo
placebo topically applied once daily for 4 treatment cycles
Interventions
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danazol
danazol applied topically once per day for 4 treatment cycles
Placebo
placebo topically applied once daily for 4 treatment cycles
Eligibility Criteria
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Inclusion Criteria
* Has moderate to severe breast pain associated with cyclical fibrocystic breast disease
* Is in good general health
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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FemmePharma Global Healthcare, Inc.
INDUSTRY
Responsible Party
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FemmePharma Global Healthcare, Inc.
Principal Investigators
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Peter K. Mays, Ph.D.
Role: STUDY_DIRECTOR
FemmePharma Global Healthcare, Inc.
Locations
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Women's Health Research
Phoenix, Arizona, United States
Advanced Clinical Therapeutics, LLC
Tucson, Arizona, United States
Impact Clinical Trials
Beverly Hills, California, United States
Women's Health Care at Frost Street
San Diego, California, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, United States
James A Simon, M.D., PC
Washington D.C., District of Columbia, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Southeastern Integrated Medical, LLC
Gainsville, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Atlanta North Gynecology, PC
Roswell, Georgia, United States
Women's Health Practice
Champaign, Illinois, United States
Center for Women's Research
Chicago, Illinois, United States
Physician's Research Group
Indianapolis, Indiana, United States
Kentucky Medical Research Center
Lexington, Kentucky, United States
MedVadis Research Corporation
Wellesley Hills, Massachusetts, United States
Impact Clinical Trials
Las Vegas, Nevada, United States
Delaware Valley OB/GYN and Infertility Group, PC
Lawrenceville, New Jersey, 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
Rochester Clinical Research, Inc.
Rochester, New York, United States
Columbus Center for Women's Health Research
Columbus, Ohio, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Southeastern Clinical Research
Chattanooga, Tennessee, United States
Jackson Clinic
Jackson, Tennessee, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Seven Oaks Women's Center
San Antonio, Texas, United States
Salt Lake Research
Salt Lake City, Utah, United States
Virginia Women's Center
Richmond, Virginia, United States
Women's Clinical Research Center
Seattle, Washington, United States
Countries
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References
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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.
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.
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. 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. doi: 10.1185/030079904125003377.
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.
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. doi: 10.1007/BF01806008.
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.
Related Links
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General breast health information
Other Identifiers
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FP1198-001
Identifier Type: -
Identifier Source: org_study_id
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