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ClomiPHENE citrate is capable of interacting with estrogen-receptor-containing tissuesincluding the hypothalamuspituitaryovaryendometriumvaginaand cervixIt may compete with estrogen for estrogen-receptor-binding sites and may delay replenishment of intracellular estrogen receptorsClomiPHENE citrate initiates a series of endocrine events culminating in a preovulatory gonadotropin surge and subsequent follicular ruptureThe first endocrine event in response to a course of clomiPHENE citrate therapy is an increase in the release of pituitary gonadotropinsThis initiates steroidogenesis and folliculogenesisresulting in growth of the ovarian follicle and an increase in the circulating level of estradiolFollowing ovulationplasma progesterone and estradiol rise and fall as they would in a normal ovulatory cycle.

Fetal/Neonatal AnomaliesThe following fetal abnormalities have also been reported during postmarketing surveillancedelayed developmentabnormal bone development including skeletal malformations of the skullfacenasal passagesjawhandlimbectromelia including ameliahemimeliaand phocomeliafootand jointstissue malformations including imperforate anustracheoesophageal fistuladiaphragmatic herniarenal agenesis and dysgenesisand malformations of the eye and lenscataractearlungheartventricular septal defect and tetralogy of Fallotand genitaliaas well as dwarfismdeafnessmental retardationchromosomal disordersand neural tube defectsincluding anencephaly

The following adverse experiences were reported spontaneously with clomiPHENE citrateThe cause and effect relationship of the listed events to the administration of clomiPHENE citrate is not known.

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