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Compared with placebo, Avodart was associated with a statistically significantly lower incidence of AUR (1. Avodart Capsules should not be handled by women who are pregnant or who may become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions (5. Therefore, for interpretation of serial PSAs in a man taking Avodart, a new baseline PSA concentration should be established after 3 to 6 months of treatment, and this new value should be used to assess potentially cancer-related changes in PSA. Avodart is a 5α-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. 5-mg daily doses of Avodart in 3 identical 2-year, placebo-controlled, double-blind, Phase 3 treatment studies, each with 2-year open-label extensions. These data suggest that Avodart arrests the disease process of BPH in men with an enlarged prostate.
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