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

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Radiant Research, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fispemifene (once daily for 8 weeks)

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

QuatRx Pharmaceuticals Company

Industry

Collaborators

Hormos Medical

Registry information

Official study 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

Important dates

Study start: 2006
Study completion: 2008
First posted: Dec 25, 2006
Registry last updated: Feb 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed