Patent ID: 7799769
Filing Date: 2010-09-21
Classification: A61K,A61P

Abstract:
1. A pharmaceutical composition formulated for administering a therapeutic female-appropriate amount of an androgen compound to a female human patient who has a condition which is associated with deficient serum androgen levels, said pharmaceutical composition comprising a safe female-appropriate unit dose of said androgen, in a pharmaceutically acceptable carrier formulated for daily topical administration to said female human patient as a gel, the safe female-appropriate unit dose of said androgen being in an amount which is both effective for alleviating the female patient's condition associated with androgen deficiency and for consistently raising the female patients' serum androgen levels only within limits approximating the reference range for normal premenopausal women, wherein the composition contains a daily unit dose of about 7.5 mg of testosterone and is formulated to provide steady state total testosterone serum levels within a range of between about 0.9 ng/mL to about 1.4 ng/mL for at least 24 hours after each daily administration without raising free testosterone serum levels or twenty-four hour free testosterone AUC above the levels required for therapeutic efficacy and safety.