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Treatment of sexually mature male rats with dutasteride at - to 110-fold the MRHD (animal doses of , 10, 50, and 500 mg/kg/day for up to 31 weeks) resulted in dose- and time-dependent decreases in fertility; reduced cauda epididymal (absolute) sperm counts but not sperm concentration (at 50 and 500 mg/kg/day); reduced weights of the epididymis , prostate, and seminal vesicles ; and microscopic changes in the male reproductive organs. The fertility effects were reversed by recovery Week 6 at all doses, and sperm counts were normal at the end of a 14-week recovery period. The 5 alpha-reductase– related changes consisted of cytoplasmic vacuolation of tubular epithelium in the epididymides and decreased cytoplasmic content of epithelium, consistent with decreased secretory activity in the prostate and seminal vesicles. The microscopic changes were no longer present at recovery Week 14 in the low-dose group and were partly recovered in the remaining treatment groups. Low levels of dutasteride ( to 17 ng/mL) were detected in the serum of untreated female rats mated to males dosed at 10, 50, or 500 mg/kg/day for 29 to 30 weeks.