Oral dosage form of both clomiphene isomers and method of using same to treat secondary hypogonadism and minimize drug side effects in men
AssigneeAspen Park Pharmaceuticals, Inc.
InventorsMitchell Steiner, Harry Fisch
Life of this patent
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Abstract
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.
Claims12
A method of treating secondary hypogonadism in a human male patient in need thereof comprising orally administering to said human male patient an effective amount therefor of 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) administered is about 70:30;
- (ii) the effective amount of (A) is about 12.5 mg per day or about 25 mg per day;
- and (iii) the effective amount of (B) is less than 15 mg per day.
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.
Dependencies are inferred from the claim text.