Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415571
• Other study ID #: 101-50608
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2006
• Last updated: February 2, 2010
• Start date: December 2006
• Est. completion date: August 2008

Study information

• Verified date: February 2010
• Source: QuatRx Pharmaceuticals Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Hypogonadism

Intervention

Drug:
• Fispemifene (once daily for 8 weeks)

Locations

Country	Name	City	State
United States	Radiant Research	Birmingham	Alabama
United States	Metrolina Urology Clinic	Charlotte	North Carolina
United States	NorthEast Urology research	Concord	North Carolina
United States	Hamilton Urology	Hamilton	New Jersey
United States	HealthStar Research	Hot Springs	Arkansas
United States	Office of Stephen Miller	Las Vegas	Nevada
United States	Genesis Research International	Longwood	Florida
United States	Urology Associates, P.C.	Nashville	Tennessee
United States	Renstar Medical Research	Ocala	Florida
United States	Radiant Research	San Antonio	Texas
United States	Regional Urology	Shreveport	Louisiana
United States	Genova Clinical Research	Tucson	Arizona
United States	Radiant Research	West Palm Beach	Florida
United States	Center for Urologic Research of WNY, LLC	Williamsville	New York

Sponsors (2)

Lead Sponsor	Collaborator
QuatRx Pharmaceuticals Company	Hormos Medical

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View 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. Epub 2006 May 23. Erratum in: J Clin Endocrinol Metab. 2006 Jul;91(7):2688. — View Citation

Campbell HE. Clinical monograph for drug formulary review: erectile dysfunction agents. J Manag Care Pharm. 2005 Mar;11(2):151-71. Review. — View Citation

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. — View 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. — View 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. — View Citation

NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993 Jul 7;270(1):83-90. Review. — View Citation

Salonia A, Rigatti P, Montorsi F. Sildenafil in erectile dysfunction: a critical review. Curr Med Res Opin. 2003;19(4):241-62. Review. — View 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. — View Citation

Shabsigh R. Testosterone therapy in erectile dysfunction and hypogonadism. J Sex Med. 2005 Nov;2(6):785-92. Review. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the IIEF erectile function domain score from baseline to Week 8/Early Termination;
Primary	Change in total testosterone levels from baseline to Week 8/Early Termination