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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. Table 1 summarizes clinical adverse reactions reported in at least 1% of subjects receiving Avodart and at a higher incidence than subjects receiving placebo. Therefore, Avodart may cause fetal harm when administered to a pregnant woman. Patients should be assessed to rule out prostate cancer and other urological diseases prior to treatment with Avodart and periodically thereafter. 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. 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.

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