NCT00415571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

February 3, 2010

Status Verified

February 1, 2010

First QC Date

December 21, 2006

Last Update Submit

February 2, 2010

Conditions

HypogonadismErectile Dysfunction

Keywords

HypogonadismErectile Dysfunction

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

Fispemifene (once daily for 8 weeks)DRUG

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Radiant Research

Birmingham, Alabama, 35209, United States

Location

Genova Clinical Research

Tucson, Arizona, 85741, United States

Location

HealthStar Research

Hot Springs, Arkansas, 71913, United States

Location

Genesis Research International

Longwood, Florida, 32779, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Radiant Research

West Palm Beach, Florida, 33407, United States

Location

Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Office of Stephen Miller

Las Vegas, Nevada, 89144, United States

Location

Hamilton Urology

Hamilton, New Jersey, 08690, United States

Location

Center for Urologic Research of WNY, LLC

Williamsville, New York, 14221, United States

Location

Metrolina Urology Clinic

Charlotte, North Carolina, 28207, United States

Location

NorthEast Urology research

Concord, North Carolina, 28025, United States

Location

Urology Associates, P.C.

Nashville, Tennessee, 37209, United States

Location

Radiant Research

San Antonio, Texas, 78229, United States

Location

Related Publications (12)

  • 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. doi: 10.1016/s0022-5347(17)34871-1.

    PMID: 8254833BACKGROUND

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

    PMID: 8510302BACKGROUND

  • 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.

    PMID: 10647654BACKGROUND

  • Campbell HE. Clinical monograph for drug formulary review: erectile dysfunction agents. J Manag Care Pharm. 2005 Mar;11(2):151-71. doi: 10.18553/jmcp.2005.11.2.151.

    PMID: 15766322BACKGROUND

  • Salonia A, Rigatti P, Montorsi F. Sildenafil in erectile dysfunction: a critical review. Curr Med Res Opin. 2003;19(4):241-62. doi: 10.1185/030079903125001839.

    PMID: 12841917BACKGROUND

  • 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. doi: 10.1210/jc.2005-2847. Epub 2006 May 23.

    PMID: 16720669BACKGROUND

  • 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. doi: 10.1385/ENDO:23:2-3:143.

    PMID: 15146093BACKGROUND

  • Shabsigh R. Testosterone therapy in erectile dysfunction and hypogonadism. J Sex Med. 2005 Nov;2(6):785-92. doi: 10.1111/j.1743-6109.2005.00139.x.

    PMID: 16422803BACKGROUND

  • 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.

    PMID: 12898793BACKGROUND

  • 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. doi: 10.1046/j.1365-2265.2003.01764.x.

    PMID: 12699447BACKGROUND

  • 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. doi: 10.1097/01.ju.0000132389.97804.d7.

    PMID: 15247755BACKGROUND

  • 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. doi: 10.1111/j.1439-0272.2006.00712.x.

    PMID: 16529577BACKGROUND

MeSH Terms

Conditions

HypogonadismErectile Dysfunction

Interventions

fispemifene

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 25, 2006

Study Start

December 1, 2006

Study Completion

August 1, 2008

Last Updated

February 3, 2010

Record last verified: 2010-02

Locations

US(14)