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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

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 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
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Change in the IIEF erectile function domain score from baseline to Week 8/Early Termination;
  2. Change in total testosterone levels from baseline to Week 8/Early Termination


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
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.

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
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

Publications:

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:
Erectile Dysfunction
Hypogonadism
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Gonadal Disorders
Endocrine System Diseases
Phosphodiesterase 5 Inhibitors
Tamoxifen
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