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

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ClinicalTrials.gov Identifier: NCT00415571

Recruitment Status : Completed

First Posted : December 25, 2006

Last Update Posted : February 3, 2010

Sponsor:

Collaborator:

Hormos Medical

Information provided by:

QuatRx Pharmaceuticals Company

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
Hypogonadism Erectile Dysfunction	Drug: Fispemifene (once daily for 8 weeks)	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	December 2006
Actual Study Completion Date :	August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Erectile Dysfunction

U.S. FDA Resources

Arms and Interventions

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

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00415571

Locations

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United States, Alabama
Radiant Research
Birmingham, Alabama, United States, 35209
United States, Arizona
Genova Clinical Research
Tucson, Arizona, United States, 85741
United States, Arkansas
HealthStar Research
Hot Springs, Arkansas, United States, 71913
United States, Florida
Genesis Research International
Longwood, Florida, United States, 32779
Renstar Medical Research
Ocala, Florida, United States, 34471
Radiant Research
West Palm Beach, Florida, United States, 33407
United States, Louisiana
Regional Urology
Shreveport, Louisiana, United States, 71106
United States, Nevada
Office of Stephen Miller
Las Vegas, Nevada, United States, 89144
United States, New Jersey
Hamilton Urology
Hamilton, New Jersey, United States, 08690
United States, New York
Center for Urologic Research of WNY, LLC
Williamsville, New York, United States, 14221
United States, North Carolina
Metrolina Urology Clinic
Charlotte, North Carolina, United States, 28207
NorthEast Urology research
Concord, North Carolina, United States, 28025
United States, Tennessee
Urology Associates, P.C.
Nashville, Tennessee, United States, 37209
United States, Texas
Radiant Research
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

QuatRx Pharmaceuticals Company

Hormos Medical

More Information

Publications:

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.

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

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.

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

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

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.

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.

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

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.

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.

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.

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.

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Responsible Party:	Janice Margulies/ Development Scientist, QUATRx
ClinicalTrials.gov Identifier:	NCT00415571 History of Changes
Other Study ID Numbers:	101-50608
First Posted:	December 25, 2006 Key Record Dates
Last Update Posted:	February 3, 2010
Last Verified:	February 2010

Keywords provided by QuatRx Pharmaceuticals Company:


Hypogonadism Erectile Dysfunction

Additional relevant MeSH terms:

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Erectile Dysfunction Hypogonadism Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Mental Disorders Gonadal Disorders Endocrine System Diseases Tamoxifen Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents

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