Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors
Sponsor
QuatRx Pharmaceuticals Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00415571
Collaborator
Hormos Medical (Industry)
72
14
20
5.1
0.3
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors: An 8-Week, Randomized, Double-Blind, Placebo-Controlled Study
Study Start Date
:
Dec 1, 2006
Actual Study Completion Date
:
Aug 1, 2008
Outcome Measures
Primary Outcome Measures
- 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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Hypogonadal (morning total testosterone levels ≤400 ng/dl) men age ≥20 with ED who are unresponsive to PDE5 inhibitors, as demonstrated by International Index of Erectile Function (IIEF) results for 28-day lead in period.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radiant Research | Birmingham | Alabama | United States | 35209 |
| 2 | Genova Clinical Research | Tucson | Arizona | United States | 85741 |
| 3 | HealthStar Research | Hot Springs | Arkansas | United States | 71913 |
| 4 | Genesis Research International | Longwood | Florida | United States | 32779 |
| 5 | Renstar Medical Research | Ocala | Florida | United States | 34471 |
| 6 | Radiant Research | West Palm Beach | Florida | United States | 33407 |
| 7 | Regional Urology | Shreveport | Louisiana | United States | 71106 |
| 8 | Office of Stephen Miller | Las Vegas | Nevada | United States | 89144 |
| 9 | Hamilton Urology | Hamilton | New Jersey | United States | 08690 |
| 10 | Center for Urologic Research of WNY, LLC | Williamsville | New York | United States | 14221 |
| 11 | Metrolina Urology Clinic | Charlotte | North Carolina | United States | 28207 |
| 12 | NorthEast Urology research | Concord | North Carolina | United States | 28025 |
| 13 | Urology Associates, P.C. | Nashville | Tennessee | United States | 37209 |
| 14 | Radiant Research | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- QuatRx Pharmaceuticals Company
- Hormos Medical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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.
- 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. Epub 2006 May 23. Erratum in: J Clin Endocrinol Metab. 2006 Jul;91(7):2688. Erratum in: J Clin Endocrinol Metab. 2021 Jun 16;106(7):e2843.
- Campbell HE. Clinical monograph for drug formulary review: erectile dysfunction agents. J Manag Care Pharm. 2005 Mar;11(2):151-71. Review.
- 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.
- 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.
- 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.
- NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993 Jul 7;270(1):83-90. Review.
- Salonia A, Rigatti P, Montorsi F. Sildenafil in erectile dysfunction: a critical review. Curr Med Res Opin. 2003;19(4):241-62. Review.
- 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.
- Shabsigh R. Testosterone therapy in erectile dysfunction and hypogonadism. J Sex Med. 2005 Nov;2(6):785-92. Review.
- 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.
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00415571
Other Study ID Numbers:
- 101-50608
First Posted:
Dec 25, 2006
Last Update Posted:
Feb 3, 2010
Last Verified:
Feb 1, 2010
Keywords provided by ,
,
Additional relevant MeSH terms: