Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: CODAL-SYNTO Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus
Pharmacotherapeutic group: Ovulation stimulants, synthetic, Sex hormones and modulators of the genital system
ATC code: G03GB02
The ovulatory response to cyclic clomifene therapy is mediated through increased output of pituitary gonadotrophins, which in turn stimulates the maturation and endocrine activity of the ovarian follicle.
Clomifene is a triarylethylene compound (related to chlorotrianisene and triparanol). It is a non-steroidal agent which stimulates ovulation in a high percentage of appropriately selected anovulatory women.
Orally administered 14C labelled Clomifene citrate was readily absorbed when administered to humans. Cumulative excretion of the 14C label by way of urine and faeces averaged about 50% of the oral dose after 5 days in 6 subjects, with mean urinary excretion of 7.8% and mean faecal excretion of 42.4%. A mean rate of excretion of 0.73% per day of the 14C dose after 31 days to 35 days and 0.45% per day of the 14C dose after 42 days to 45 days was seen in faecal and urine samples collected from 6 subjects for 14 to 53 days after Clomifene citrate 14C administration.
The remaining drug/metabolites may be slowly excreted from a sequestered enterohepatic recirculation pool.
Prolonged use of clomifene citrate may increase the risk of developing ovarian cancer.
Long term toxicity studies in animals have not been performed to evaluate the carcinogenic potential of clomifene citrate.
Mutagenic potential of clomifene citrate has not been evaluated.
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