Clinical trial NCT00415571: Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypogonadism
Erectile Dysfunction
Keywords: Hypogonadism
Erectile Dysfunction
Lead sponsor: QuatRx Pharmaceuticals Company
Sponsor class: INDUSTRY
Collaborators: name: Hormos Medical
First posted: 2006-12-25
Enrollment: 72
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the IIEF erectile function domain score from baseline to Week 8/Early Termination;
measure: Change in total testosterone levels from baseline to Week 8/Early Termination
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Hot Springs
country: United States
facility: HealthStar Research
state: Arkansas
city: Longwood
country: United States
facility: Genesis Research International
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: West Palm Beach
country: United States
facility: Radiant Research
state: Florida
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Las Vegas
country: United States
facility: Office of Stephen Miller
state: Nevada
city: Hamilton
country: United States
facility: Hamilton Urology
state: New Jersey
city: Williamsville
country: United States
facility: Center for Urologic Research of WNY, LLC
state: New York
city: Charlotte
country: United States
facility: Metrolina Urology Clinic
state: North Carolina
city: Concord
country: United States
facility: NorthEast Urology research
state: North Carolina
city: Nashville
country: United States
facility: Urology Associates, P.C.
state: Tennessee
city: San Antonio
country: United States
facility: Radiant Research
state: Texas
Study officials:
References:
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citation: NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993 Jul 7;270(1):83-90. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.