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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. Avodart is contraindicated for use in women of childbearing potential and during pregnancy. During the first 2 years, 1,623 subjects received monotherapy with Avodart; 1,611 subjects received monotherapy with tamsulosin; and 1,610 subjects received combination therapy. Table 1 summarizes clinical adverse reactions reported in at least 1% of subjects receiving Avodart and at a higher incidence than subjects receiving placebo. If Avodart is used during pregnancy or if the patient becomes pregnant while taking Avodart, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5. Avodart is a 5α-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia.
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