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Over 2years of treatment, drug-related ejaculation disorders occurred more frequently in subjects receiving combination therapy (9%) compared to Avodart (2%) or tamsulosin (3%) as monotherapy. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men receiving Avodart, no adjustment to its value appears necessary. To avoid potential fetal exposure, women who are pregnant or may become pregnant should not handle Avodart Soft Gelatin Capsules. 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. Most of the 4,844subjects randomly assigned to receive combination, Avodart, or tamsulosin completed 2years of double-blind treatment (79%, 80%, and 78%, respectively). Table1 summarizes clinical adverse reactions reported in at least 1% of subjects receiving Avodart and at a higher incidence than subjects receiving placebo.
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