A typical carcinogenesis research in rats at dosages of 1.0 to 25 mg/kg/day(regarding 10 to 243 times the day-to-day optimum advised human dose on a mg/m2 basis) provided by dental gavage for around 2 years disclosed an increase in the incidence of hepatocellular adenoma as well as carcinoma and uterine stromal polyps in females as well as thyroid adenoma in males at the high dosage. A dose-related rise was observed in the occurrence of ovarian and also uterine hyperplasia in females.
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At 25 mg/kg/day, plasma AUC0-24 hr levels in rats were 110 to 125 times greater than the level showed in postmenopausal volunteers at the advised dose. A different carcinogenicity research in computer mice at dental doses of 5 to 50 mg/kg/day(concerning 24 to 243 times the day-to-day optimum advised human dose on a mg/m2 basis )for up to 2 years produced a rise in the incidence of benign ovarian stromal, epithelial as well as granulosa cell tumors whatsoever dosage degrees. A dose-related increase in the incidence of ovarian hyperplasia was likewise noted in women computer mice. These ovarian changes are thought about to be rodent-specific results of aromatase restraint and also are of suspicious relevance to people. The occurrence of lymphosarcoma was increased in men and also females at the high dose. At 50 mg/kg/day, plasma AUC levels in computer mice were 35 to 40 times more than the level exhibited in postmenopausal volunteers at the suggested dosage.