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Results
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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%) |
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|
| 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of each treatment group) were withdrawn from the studies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. |
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