MILOPHENE

Pharmacokinetics Based on early studies with 14 C-labeled clomiphene citrate, the drug was shown to be readily absorbed orally in humans and excreted principally in the feces. Cumulative urinary and fecal excretion of the 14 C averaged about 50% of the oral dose and 37% of an intravenous dose after 5 days. Mean urinary excretion was approximately 8% with fecal excretion of about 42%. Some 14 C label was still present in the feces 6 weeks after administration. Subsequent single-dose studies in no...

CLINICAL STUDIES During clinical investigations, 7578 patients received clomiphene citrate, some of whom had impediments to ovulation other than ovulatory dysfunction (see INDICATIONS AND USAGE ). In those clinical trials, successful therapy characterized by pregnancy occurred in approximately 30% of these patients. There were a total of 2635 pregnancies reported during the clinical trial period. Of those pregnancies, information on outcome was only available for 2369 of the cases. Table 1 summarizes the outcome of these cases. Of the reported pregnancies, the incidence of multiple pregnancies...

ADVERSE REACTIONS Clinical Trial Adverse Events. Clomiphene citrate, at recommended dosages, is generally well tolerated. Adverse reactions usually have been mild and transient and most have disappeared promptly after treatment has been discontinued. Adverse experiences reported in patients treated with clomiphene citrate during clinical studies are shown in Table 2 .

Table 2Incidence of Adverse Events in Clinical Studies (Events Greater than 1%) (n = 8029*) *Includes 498 patients whose report...

CONTRAINDICATIONS Hypersensitivity Clomiphene citrate is contraindicated in patients with a known hypersensitivity or allergy to clomiphene citrate or to any of its ingredients. Pregnancy Clomiphene citrate use in pregnant women is contraindicated, as clomiphene citrate does not offer benefit in this population. Available human data do not suggest an increased risk for congenital anomalies above t...