ORAL DOSED FORM OF TWO CLOMIPHENES ISOMERS AND METHOD OF ITS USE FOR TREATMENT OF SECONDARY HYPOGONADISM AND MINIMIZATION OF ADVERSE EFFECTS OF THE MEDICINE IN MEN
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.
