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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. Avodart is contraindicated for use in women of childbearing potential and during pregnancy. Compared with placebo, Avodart was associated with a statistically significantly lower incidence of AUR (1. 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.

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