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

• ClinicalTrials.gov Identifier: NCT00415571
• Recruitment Status: Completed
• First Posted: December 25, 2006
• Last Update Posted: February 3, 2010
• Sponsor: QuatRx Pharmaceuticals Company
• Collaborator: Hormos Medical
• Information provided by: QuatRx Pharmaceuticals Company

Tracking Information

• First Submitted Date: December 21, 2006
• First Posted Date: December 25, 2006
• Last Update Posted Date: February 3, 2010
• Study Start Date: December 2006
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: February 23, 2007)

• 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

Original Primary Outcome Measures (submitted: December 22, 2006)

• 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

• Change History: Complete list of historical versions of study NCT00415571 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: December 22, 2006)

• Change in total testosterone levels from baseline to Week 4 and Week 10
• ;Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 4, 8/Early Termination and 10
• ;Change in SHBG, E2, LH, FSH, and testosterone/E2 ratio from baseline to Weeks 4, 8/Early Termination and 10
• ;Change in the IIEF erectile function domain score from baseline to Week 4
• ;Change in other IIEF domain scores from baseline to Weeks 4 and 8/Early Termination
• ;Change in IIEF individual question scores and total score from baseline to Weeks 4 and 8/Early Termination
• ;Proportion of “responders” defined as response of 4 or 5 to questions 3 and 4 of the IIEF at Weeks 4 and 8/Early Termination
• ;Proportion of “improvers” defined as an increase of at least 1 category over baseline for either question 3 or 4 at Weeks 4 and 8/Early Termination
• ;Percentage of subjects with a “YES” responses to the GAQ, when asked at Week 8/Early Termination
• ;Change in serum lipid levels from screening to Week 8/Early Termination

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Hypogonadism
• Erectile Dysfunction

• Intervention: Drug: Fispemifene (once daily for 8 weeks)
• Study Arms: Not Provided

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.

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: December 22, 2006): 72
• Original Enrollment: Same as current
• Actual Study Completion Date: August 2008
• Primary Completion Date: Not Provided

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00415571
• Other Study ID Numbers: 101-50608
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Janice Margulies/ Development Scientist, QUATRx
• Study Sponsor: QuatRx Pharmaceuticals Company
• Collaborators: Hormos Medical
• Investigators: Not Provided
• PRS Account: QuatRx Pharmaceuticals Company
• Verification Date: February 2010