Dutasteride Safety Profile

Safety Profile

DUTASTERIDE PHASE 3 BPH TRIAL
SIDE EFFECTS
Dose – 0.5 mg

Side Effect Observed Placebo (N=2158)  Actual Drug (N=2166)
Impotence 59 (3%) 117 (5%)
Decreased Libido 40 (2%) 74 (3%)
Ejaculation Disorders 14 (<1%) 40 (2%)
Gynecomastia 10 (<1%) 29 (1%)
The Phase III BPH trials for Dutasteride were conducted on 4300 male subjects between the ages of 47 and 94 years old, 90% of them being Caucasian. The average age was 66 years old and the participants received either a placebo or a 0.5mg daily dose of Dutasteride. 2158 men received the placebo and 2166 of the men received Dutasteride. A total of 267 subjects (6% of each treatment group) were withdrawn from the studies due to adverse experiences, usually associated with the reproductive system. Withdrawal due to adverse events considered by the investigators to have a reasonable possibility of being caused by the medication occurred in 3% of the subjects receiving Dutasteride and in 2% of the subjects receiving the placebo.