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When including the open-label extensions, 1,009 male subjects were exposed to Avodart for 3 years and 812 were exposed for 4 years. 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. Although the effect of administration of tamsulosin or terazosin on dutasteride pharmacokinetic parameters was not evaluated, the percent change in DHT concentrations was similar for Avodart alone compared with the combination treatment. Compared with placebo, Avodart was associated with a statistically significantly lower incidence of AUR (1. Avodart is contraindicated for use in women of childbearing potential and during pregnancy. 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.

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