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?The following fetal abnormalities have been reported subsequent to pregnancies following ovulation induction therapy with clomiPHENE citrate during clinical trials. ? ClomiPHENE citrate initiates a series of endocrine events culminating in a preovulatory gonadotropin surge and subsequent follicular rupture. ? The overall incidence of reported birth anomalies from pregnancies associated with maternal clomiPHENE citrate ingestion during clinical studies was within the range of that reported for the general population. ? Endometrial biopsy should always be performed prior to clomiPHENE citrate therapy in this population. ? ClomiPHENE citrate may cause fetal harm in animals (see Animal Fetotoxicity). ? Thus, it is possible that some active drug may remain in the body during early pregnancy in women who conceive in the menstrual cycle during clomiPHENE citrate therapy. ? Although no causative evidence of a deleterious effect of clomiPHENE citrate therapy on the human fetus has been established, there have been reports of birth anomalies which, during clinical studies, occurred at an incidence within the range reported for the general population (see Fetal/Neonatal Anomalies and Mortality; ADVERSE REACTIONS). ? Pelvic examination is necessary prior to the first and each subsequent course of clomiPHENE citrate treatment. ? Some data suggest that zuclomiPHENE has greater estrogenic activity than enclomiPHENE. ? Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiPHENE citrate therapy. ? Caution should be exercised when using clomiPHENE citrate in patients with uterine fibroids due to the potential for further enlargement of the fibroids. ? The next course of clomiPHENE citrate therapy should be delayed until these conditions have been excluded. ? ClomiPHENE citrate is contraindicated in patients with abnormal uterine bleeding of undetermined origin (see INDICATIONS AND USAGE). ? This may be suggestive of stereo-specific enterohepatic recycling or sequestering of the zuclomiPHENE. ? The two clomiPHENE isomers have been found to have mixed estrogenic and antiestrogenic effects, which may vary from one species to another. ? Subsequent single-dose studies in normal volunteers showed that zuclomiPHENE (cis) has a longer half-life than enclomiPHENE (trans). ? The first endocrine event in response to a course of clomiPHENE citrate therapy is an increase in the release of pituitary gonadotropins. ? The cause and effect relationship between reports of testicular tumors and the administration of clomiPHENE citrate is not known. ? Detectable levels of zuclomiPHENE persisted for longer than a month in these subjects. ? Similarly, there is no standard clomiPHENE citrate regimen for ovulation induction in in vitro fertilization programs to produce ova for fertilization and reintroduction. As with clomiphene, some men respond favorably to tamoxifen and show improved semen quality and increased rates of conception; however, there are still questions regarding which patient groups are most likely to be helped by tamoxifen therapy. shtml"Tamoxifen, like clomiphene citrate, is an oral anti-estrogen compound that has been used to treat male infertility. ? ClomiPHENE citrate therapy is contraindicated in patients with liver disease or a history of liver dysfunction (see also INDICATIONS AND USAGE and ADVERSE REACTIONS). ? ClomiPHENE citrate should not be used in patients with ovarian enlargement except in those with polycystic ovary syndrome. ? ClomiPHENE citrate therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure. ? Oral administration of clomiPHENE citrate to pregnant rats during organogenesis at doses of 1 to 2 mg/kg/day resulted in hydramnion and weak, edematous fetuses with wavy ribs and other temporary bone changes. ? Those patients most likely to achieve success with clomiPHENE therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. ? With careful selection and proper management of the patient, clomiPHENE citrate has been demonstrated to be a useful therapy for the anovulatory patient desiring pregnancy. ? In addition, testicular tumors and gynecomastia have been reported in males using clomiPHENE.

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