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| Name | Class |
|---|---|
| Hormos Medical | INDUSTRY |
The objective of the study is to assess and compare the preliminary efficacy, safety and tolerability of fispemifene 300 mg and placebo given once daily for 8 weeks in the treatment of hypogonadal men with erectile dysfunction (ED) unresponsive to PDE5 inhibitors.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fispemifene (once daily for 8 weeks) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the IIEF erectile function domain score from baseline to Week 8/Early Termination; | ||
| Change in total testosterone levels from baseline to Week 8/Early Termination |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Birmingham | Alabama | 35209 | United States | ||
| Genova Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8254833 | Background | Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1. | |
| 8510302 | Background | NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993 Jul 7;270(1):83-90. No abstract available. |
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| Tucson |
| Arizona |
| 85741 |
| United States |
| HealthStar Research | Hot Springs | Arkansas | 71913 | United States |
| Genesis Research International | Longwood | Florida | 32779 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Radiant Research | West Palm Beach | Florida | 33407 | United States |
| Regional Urology | Shreveport | Louisiana | 71106 | United States |
| Office of Stephen Miller | Las Vegas | Nevada | 89144 | United States |
| Hamilton Urology | Hamilton | New Jersey | 08690 | United States |
| Center for Urologic Research of WNY, LLC | Williamsville | New York | 14221 | United States |
| Metrolina Urology Clinic | Charlotte | North Carolina | 28207 | United States |
| NorthEast Urology research | Concord | North Carolina | 28025 | United States |
| Urology Associates, P.C. | Nashville | Tennessee | 37209 | United States |
| Radiant Research | San Antonio | Texas | 78229 | United States |
| 10647654 | Background | Johannes CB, Araujo AB, Feldman HA, Derby CA, Kleinman KP, McKinlay JB. Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts male aging study. J Urol. 2000 Feb;163(2):460-3. |
| 15766322 | Background | Campbell HE. Clinical monograph for drug formulary review: erectile dysfunction agents. J Manag Care Pharm. 2005 Mar;11(2):151-71. doi: 10.18553/jmcp.2005.11.2.151. |
| 12841917 | Background | Salonia A, Rigatti P, Montorsi F. Sildenafil in erectile dysfunction: a critical review. Curr Med Res Opin. 2003;19(4):241-62. doi: 10.1185/030079903125001839. |
| 16720669 | Background | Bhasin S, Cunningham GR, Hayes FJ, Matsumoto AM, Snyder PJ, Swerdloff RS, Montori VM. Testosterone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2006 Jun;91(6):1995-2010. doi: 10.1210/jc.2005-2847. Epub 2006 May 23. |
| 15146093 | Background | Albrecht-Betancourt M, Hijazi RA, Cunningham GR. Androgen replacement in men with hypogonadism and erectile dysfunction. Endocrine. 2004 Mar-Apr;23(2-3):143-8. doi: 10.1385/ENDO:23:2-3:143. |
| 16422803 | Background | Shabsigh R. Testosterone therapy in erectile dysfunction and hypogonadism. J Sex Med. 2005 Nov;2(6):785-92. doi: 10.1111/j.1743-6109.2005.00139.x. |
| 12898793 | Background | Kalinchenko SY, Kozlov GI, Gontcharov NP, Katsiya GV. Oral testosterone undecanoate reverses erectile dysfunction associated with diabetes mellitus in patients failing on sildenafil citrate therapy alone. Aging Male. 2003 Jun;6(2):94-9. |
| 12699447 | Background | Aversa A, Isidori AM, Spera G, Lenzi A, Fabbri A. Androgens improve cavernous vasodilation and response to sildenafil in patients with erectile dysfunction. Clin Endocrinol (Oxf). 2003 May;58(5):632-8. doi: 10.1046/j.1365-2265.2003.01764.x. |
| 15247755 | Background | Shabsigh R, Kaufman JM, Steidle C, Padma-Nathan H. Randomized study of testosterone gel as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone. J Urol. 2004 Aug;172(2):658-63. doi: 10.1097/01.ju.0000132389.97804.d7. |
| 16529577 | Background | Yassin AA, Saad F, Diede HE. Testosterone and erectile function in hypogonadal men unresponsive to tadalafil: results from an open-label uncontrolled study. Andrologia. 2006 Apr;38(2):61-8. doi: 10.1111/j.1439-0272.2006.00712.x. |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C532124 | fispemifene |
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