NCT01831791

A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia

Study ARI114264: A Long-Term Study of the Safety and Efficacy of Dutasteride in the Treatment of Male Subjects With Androgenetic Alopecia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a multicentre, open-label study to assess the safety, tolerability, and efficacy of 0.5 mg Dutasteride administered once daily for 52 weeks in men with Androgenetic Alopecia types III vertex, IV and V per the Norwood-Hamilton classification. The study consists of a Screening Phase (3 weeks prior to Baseline) and a Treatment Phase (52 weeks). A subject who completes the full course of study treatment and the final study visit (Week 52; Visit 7) will be considered as study completion.

Conditions

• Alopecia

Interventions

Type	Name	Description
DRUG	Dutasteride 0.5 mg	Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of Dutasteride and it will be packaged in high-density polyethylene (HDPE) bottles with plastic child-resistant closures.

Timeline

• Start date: 2013-04-14
• Primary completion: 2014-07-19
• Completion: 2014-07-19
• First posted: 2013-04-15
• Last updated: 2018-06-20
• Results posted: 2015-03-12

Locations

5 sites across 1 country: Japan