NCT02014584

Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia

A Prospective Study of Sexual Function in Men Taking Dutasteride for the Treatment of Androgenetic Alopecia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Treatment of male pattern hair loss (MPHL) or androgenetic alopecia (AGA) with 5α-reductase inhibitor (5-ARIs) has been associated with sexual dysfunction including erectile dysfunction and loss of libido. This will be a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the impact of dutasteride treatment on sexual function as well as subject satisfaction with hair growth and quality of life in men with AGA. This study will consist of a Screening Visit, a 4-week Placebo Run-in Phase, a Treatment Phase of 48 weeks, and a subsequent Follow-up Visit after 4 weeks. The treatment phase will include 24 weeks of double-blind, placebo controlled treatment and 24 weeks of open-label treatment with dutasteride. An extended 6-month Follow-up Visit will be conducted for any individuals with a change in erectile function at the end of treatment.

Conditions

• Alopecia

Interventions

Type	Name	Description
DRUG	Dutasteride	Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of dutasteride to be administered orally.
DRUG	Placebo	Dutasteride matching placebo will be supplied as capsules to be administered orally.

Timeline

• Start date: 2014-07-02
• Primary completion: 2016-03-19
• Completion: 2016-03-19
• First posted: 2013-12-18
• Last updated: 2018-10-11
• Results posted: 2017-03-08

Locations

18 sites across 5 countries: Chile, Hong Kong, Singapore, South Korea, Taiwan