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

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


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Enrollment: 160
Study Start Date: May 2015
Estimated Study Completion Date: April 2016
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Fispemifene 450 mg
- Placebo Comparator: Placebo