ORAL DOSAGE FORM OF BOTH CLOMIPHENE ISOMERS AND METHOD OF USING SAME TO TREAT SECONDARY HYPOGONADISM.

摘要

The present invention relates to a pharmaceutical oral dosage form comprising both (A) trans-clomiphene or a pharmaceutically acceptable salt thereof and (B) cis-clomiphene or a pharmaceutically acceptable salt thereof, wherein (i) the ratio of (A):(B) in the dosage form is about 70:30; (ii) the amount of (A) in the dosage form is about 12.5 mg or about 25 mg; and (iii) the amount of (B) in the dosage form is less than 15 mg. The pharmaceutical oral dosage form is useful to treat secondary hypogonadism in men and minimize certain antiestrogenic drug side effects such as impaired cognition, hot flashes and bone loss, osteoporosis, and skeletal fractures.