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Safety and Efficacy Study of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men

Erectile Dysfunction Clinical Trial

Official title:
An 8-Week Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral Fispemifene for the Treatment of Sexual Dysfunction in Hypogonadal Men

Clinical Trial Summary

To evaluate the safety and efficacy of fispemifene in men with secondary hypogonadism and sexual side effects.

Clinical Trial Description

This phase 2 study is a double-blind, placebo controlled, parallel arm study with a 4 week run-in and an 8-week treatment period. It will assess the safety and tolerability of fispemifene, and the effects of treatment on the sexual side effects seen in this patient population using PRO endpoints. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02443090
Study type Interventional
Source NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 2015
Completion date April 2016
View Details
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