NCT02443090

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.) · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Secondary Hypogonadism
• Sexual Dysfunction
• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	fispemifene
OTHER	Placebo

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-10-01
• Completion: 2016-04-01
• First posted: 2015-05-13
• Last updated: 2015-11-13

Locations

16 sites across 1 country: United States