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| Name | Class |
|---|---|
| Hormos Medical | INDUSTRY |
The purpose of this study is to determine whether one or more fispemifene dose regimens are more effective than placebo in the treatment of hypogonadism in older men.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fispemifene once daily for 4 weeks | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in morning total testosterone levels from baseline to Week 4 (end of therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total testosterone levels from baseline to Weeks 2 and 6 | ||
| Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6 | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janne Komi, MD, PhD | Hormos Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Site | Huntsville | Alabama | 35801 | United States | ||
| Clinical Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25009850 | Background | Institute of Medicine (US) Committee on Assessing the Need for Clinical Trials of Testosterone Replacement Therapy; Liverman CT, Blazer DG, editors. Testosterone and Aging: Clinical Research Directions. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216173/ | |
| 11158037 | Background |
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| Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6 |
| Modesto |
| California |
| 95350 |
| United States |
| Clinical Research Site | Aurora | Colorado | 80012 | United States |
| Clinical Research Site | Waterbury | Connecticut | 06708 | United States |
| Clinical Research Site | New Port Richey | Florida | 34652 | United States |
| Clinical Research Site | Tallahassee | Florida | 32308 | United States |
| Clinical Research Site | Peoria | Illinois | 61614 | United States |
| Clinical Research Site | Greenbelt | Maryland | 20770 | United States |
| Clinical Research Site | Las Vegas | Nevada | 89109 | United States |
| Clinical Research Site | Garden City | New York | 11530 | United States |
| Clinical Research Site | Poughkeepsie | New York | 12601 | United States |
| Clinical Research Site | Williamsville | New York | 14221 | United States |
| Clinical Research Site | Bethany | Oklahoma | 73008 | United States |
| Clinical Research Site | Greer | South Carolina | 29650 | United States |
| Clinical Research Site | San Antonio | Texas | 78229 | United States |
| Clinical Research Site | Seattle | Washington | 98166 | United States |
| Harman SM, Metter EJ, Tobin JD, Pearson J, Blackman MR; Baltimore Longitudinal Study of Aging. Longitudinal effects of aging on serum total and free testosterone levels in healthy men. Baltimore Longitudinal Study of Aging. J Clin Endocrinol Metab. 2001 Feb;86(2):724-31. doi: 10.1210/jcem.86.2.7219. |
| 11836290 | Background | Feldman HA, Longcope C, Derby CA, Johannes CB, Araujo AB, Coviello AD, Bremner WJ, McKinlay JB. Age trends in the level of serum testosterone and other hormones in middle-aged men: longitudinal results from the Massachusetts male aging study. J Clin Endocrinol Metab. 2002 Feb;87(2):589-98. doi: 10.1210/jcem.87.2.8201. |
| 15951102 | Background | Nieschlag E, Swerdloff R, Behre HM, Gooren LJ, Kaufman JM, Legros JJ, Lunenfeld B, Morley JE, Schulman C, Wang C, Weidner W, Wu FC; International Society of Andrology (ISA); International Society for the Study of the Aging Male (ISSAM); European Association of Urology (EAU). Investigation, treatment and monitoring of late-onset hypogonadism in males. ISA, ISSAM, and EAU recommendations. Eur Urol. 2005 Jul;48(1):1-4. doi: 10.1016/j.eururo.2005.04.027. No abstract available. |
| 12198738 | Background | Morales A, Lunenfeld B; International Society for the Study of the Aging Male. Investigation, treatment and monitoring of late-onset hypogonadism in males. Official recommendations of ISSAM. International Society for the Study of the Aging Male. Aging Male. 2002 Jun;5(2):74-86. No abstract available. |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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