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

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

U.S. FDA Resources

Further study details as provided by QuatRx Pharmaceuticals Company:

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

Estimated Enrollment:	72
Study Start Date:	December 2006
Study Completion Date:	August 2008

Eligibility

Ages Eligible for Study:	20 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415571

Locations

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.

[No authors listed] NIH Consensus Conference. Impotence. NIH Consensus Development Panel on Impotence. JAMA. 1993 Jul 7;270(1):83-90. Review. No abstract available.

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.

Responsible Party:	Janice Margulies/ Development Scientist, QUATRx
ClinicalTrials.gov Identifier:	NCT00415571 History of Changes
Other Study ID Numbers:	101-50608
Study First Received:	December 21, 2006
Last Updated:	February 2, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by QuatRx Pharmaceuticals Company:

Hypogonadism
Erectile Dysfunction

Additional relevant MeSH terms:

Hypogonadism
Erectile Dysfunction
Gonadal Disorders
Endocrine System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological

Sexual and Gender Disorders
Mental Disorders
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013