Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia
Status:
Completed
Trial end date:
2016-03-19
Target enrollment:
Participant gender:
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.