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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
| |
| 4 | Placebo Comparator |
| |
| 5 | Placebo Comparator |
| |
| 6 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| danazol | Drug | danazol applied topically once per day for 4 treatment cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject reported breast pain as measured using a visual analog scale on the subject daily diary | 2 cycles pretreatment plus 4 cycles on treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Physician assessment of breast nodularity at each treatment cycle visit | 2 cycles pretreatment plus 4 cycles on treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter K. Mays, Ph.D. | FemmePharma Global Healthcare, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Health Research | Phoenix | Arizona | 85015 | United States | ||
| Advanced Clinical Therapeutics, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2890912 | Background | 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. | |
| 3117172 | Background | 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. |
| Label | URL |
|---|---|
| General breast health information | View source |
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| Placebo | Drug | placebo topically applied once daily for 4 treatment cycles |
|
| Tucson |
| Arizona |
| 85712 |
| United States |
| Impact Clinical Trials | Beverly Hills | California | 90211 | United States |
| Women's Health Care at Frost Street | San Diego | California | 92123 | United States |
| Horizons Clinical Research Center, LLC | Denver | Colorado | 80220 | United States |
| James A Simon, M.D., PC | Washington D.C. | District of Columbia | 20036 | United States |
| Visions Clinical Research | Boynton Beach | Florida | 33437 | United States |
| Southeastern Integrated Medical, LLC | Gainsville | Florida | 32607 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| Atlanta North Gynecology, PC | Roswell | Georgia | 30075 | United States |
| Women's Health Practice | Champaign | Illinois | 61820 | United States |
| Center for Women's Research | Chicago | Illinois | 60612 | United States |
| Physician's Research Group | Indianapolis | Indiana | 46250 | United States |
| Kentucky Medical Research Center | Lexington | Kentucky | 40504 | United States |
| MedVadis Research Corporation | Wellesley Hills | Massachusetts | 02481-2106 | United States |
| Impact Clinical Trials | Las Vegas | Nevada | 89106 | United States |
| Delaware Valley OB/GYN and Infertility Group, PC | Lawrenceville | New Jersey | 08648 | United States |
| Phoenix OB-GYN Associates | Moorestown | New Jersey | 08057 | United States |
| UMDNJ Robert Wood Johnson Medica School Women's Health Institute | New Brunswick | New Jersey | 08901 | United States |
| Analgesic Development, Ltd. | New York | New York | 10022-1009 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Columbus Center for Women's Health Research | Columbus | Ohio | 43213 | United States |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102-1192 | United States |
| Southeastern Clinical Research | Chattanooga | Tennessee | 37403 | United States |
| Jackson Clinic | Jackson | Tennessee | 38305 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Seven Oaks Women's Center | San Antonio | Texas | 78229 | United States |
| Salt Lake Research | Salt Lake City | Utah | 84107 | United States |
| Virginia Women's Center | Richmond | Virginia | 23233 | United States |
| Women's Clinical Research Center | Seattle | Washington | 98105 | United States |
| 2364227 | Background | Gateley CA, Mansel RE. Management of cyclical breast pain. Br J Hosp Med. 1990 May;43(5):330-2. |
| 2406750 | Background | Barbieri RL. Danazol: molecular, endocrine, and clinical pharmacology. Prog Clin Biol Res. 1990;323:241-52. No abstract available. |
| 15140333 | Background | 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. |
| 12022387 | Background | 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. |
| 571588 | Background | Sitruk-Ware R, Sterkers N, Mauvais-Jarvis P. Benign breast disease I: hormonal investigation. Obstet Gynecol. 1979 Apr;53(4):457-60. |
| 3902125 | Background | Wang DY, Fentiman IS. Epidemiology and endocrinology of benign breast disease. Breast Cancer Res Treat. 1985;6(1):5-36. doi: 10.1007/BF01806008. |
| 1390280 | Background | 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. |
| ID | Term |
|---|---|
| D005348 | Fibrocystic Breast Disease |
| D059373 | Mastodynia |
| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003613 | Danazol |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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