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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. Over 2?years of treatment, drug-related ejaculation disorders occurred more frequently in subjects receiving combination therapy (9%) compared to Avodart (2%) or tamsulosin (3%) as monotherapy. Avodart is a 5α-reductase inhibitor that prevents conversion of testosterone to dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. When including the open-label extensions, 1,009?male subjects were exposed to Avodart for 3?years and 812 were exposed for 4?years. Because of the potential for drug-drug interactions, use caution when prescribing Avodart to patients taking potent, chronic CYP3A4 enzyme inhibitors (e. 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.

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