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Serophene is indicated in the treatment of ovulatory failure in patients desiring pregnancywhose partners have adequate sperm and who have potentially functional hypothalamic-hypophyseal ovarian systems and adequate endogenous oestrogensImpediments to this goal must be excluded or adequately treated before beginning therapyAdministration of Serophene is indicated only in patients with demonstrated ovulatory dysfunction and in whom the following conditions apply1Demonstration of normal liver function2Physiological indications of normal or near normal endogenous oestrogen levels should be presentas estimated from vaginal smearsendometrial biopsyassay of urinary or serum oestrogen or from bleeding in response to progesteroneReduced oestrogen levelswhile less favourabledo not prevent successful therapy3Clomiphene citrate therapy is not effective in patients with primary pituitary or ovarian failureIt cannot substitute for appropriate therapy of other disturbances leading to ovulatory dysfunctione.gdiseases of the thyroid or adrenals4Patients with abnormal uterine bleeding should be thoroughly evaluated prior to initiating clomiphene citrate therapyIt is most important that neoplastic lesions are detected.

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.

A sextuplet birth was reported after completion of original clinical studiesnone of the sextuplets survivedeach weighed less than 400 galthough each appeared grossly normal.

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