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

Sponsors and Collaborators:	QuatRx Pharmaceuticals Company Hormos Medical
Information provided by:	QuatRx Pharmaceuticals Company
ClinicalTrials.gov Identifier:	NCT00415571

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 II

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Fispemifene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date:	June 2007

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	Recruiting
Birmingham, Alabama, United States, 35209
Contact: Spencer Boddy 205-870-8803 ext 31
Principal Investigator: Chivers Woodruff, M.D.
United States, Arizona
Genova Clinical Research	Recruiting
Tucson, Arizona, United States, 85741
Contact: Norma Barrientos 520-219-6394
Principal Investigator: Leah Schmidt, D.O.
United States, Arkansas
HealthStar Research	Terminated
Hot Springs, Arkansas, United States, 71913
United States, Florida
Genesis Research International	Recruiting
Longwood, Florida, United States, 32779
Contact: Denise Owens 407-331-9505
Principal Investigator: Raul Tamayo, M.D.
Renstar Medical Research	Recruiting
Ocala, Florida, United States, 34471
Contact: Angella Anderson 352-629-5800 ext 118
Principal Investigator: Charles King, M.D.
Radiant Research	Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Stacey Mollo 561-845-1030 ext 29
Principal Investigator: Hal Bashein, M.D.
United States, Louisiana
Regional Urology	Recruiting
Shreveport, Louisiana, United States, 71106
Contact: Tracey Robinson 318-683-0411 ext 173
Principal Investigator: Gerard Henry, M.D.
United States, Nevada
Office of Stephen Miller	Recruiting
Las Vegas, Nevada, United States, 89144
Contact: Regina Almarez 702-371-7256
Principal Investigator: Stephen Miller, m.D.
United States, New Jersey
Hamilton Urology	Terminated
Hamilton, New Jersey, United States, 08690
United States, New York
Center for Urologic Research of WNY, LLC	Terminated
Williamsville, New York, United States, 14221
United States, North Carolina
Metrolina Urology Clinic	Terminated
Charlotte, North Carolina, United States, 28207
NorthEast Urology research	Terminated
Concord, North Carolina, United States, 28025
United States, Tennessee
Urology Associates, P.C.	Terminated
Nashville, Tennessee, United States, 37209
United States, Texas
Radiant Research	Recruiting
San Antonio, Texas, United States, 78229
Contact: Eileen Mollica 210-614-7483 ext 231
Principal Investigator: William Jennings, M.D.

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:	QUATRx ( Janice Margulies/ Development Scientist )
Study ID Numbers:	101-50608
Study First Received:	December 21, 2006
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00415571
Health Authority:	United States: Food and Drug Administration

Keywords provided by QuatRx Pharmaceuticals Company:

Hypogonadism
Erectile Dysfunction

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Hypogonadism
Mental Disorders
Gonadal Disorders

Endocrine System Diseases
Endocrinopathy
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual and Gender Disorders

ClinicalTrials.gov processed this record on January 16, 2009