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In an embryo-fetal development study, expecting rats received finasteride during the duration of major organogenesis (gestation days 6 to 17). At maternal doses of dental finasteride approximately 0.1 to 86 times the maximum recommended human dosage (MRHD) of 5 mg/day (based on AUC at animal doses of 0.1 to 100 mg/kg/day) there was a dose-dependent boost in hypospadias that took place in 3.6 to 100 % of male spawn. Exposure multiples were estimated using information from nonpregnant rats. Days 16 to 17 of gestation is an important period in male fetal rats for differentiation of the outside genitalia. At dental parental dosages roughly 0.03 times the MRHD (based upon AUC at pet dose of 0.03 mg/kg/day), male young had reduced seminal and prostatic vesicular weights, postponed preputial splitting up and also short-term nipple development. Lowered anogenital distance took place in male spawn of expectant rats that obtained about 0.003 times the MRHD (based on AUC at pet dosage of 0.003 mg/kg/day). No abnormalities were noted in women young at any sort of maternal dose of finasteride.





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No developing abnormalities were noted in the spawn of without treatment females mated with finasteride dealt with male rats that obtained approximately 61 times the MRHD (based upon AUC at animal dosage of 80 mg/kg/day). Slightly reduced fertility was noted in male offspring after management of about 3 times the MRHD (based on AUC at animal dosage of 3 mg/kg/day) to female rats during late gestation as well as lactation. No results on fertility were viewed in female spawn under these conditions.

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