Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels
AssigneeBayer Intellectual Property GmbH
InventorsDoris Hubler, Sabine Fricke, Jan-Peter Ingwersen, Wilheim Kuhnz
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Abstract
Described are methods for providing prolonged physiologically acceptable steady state serum testosterone levels in a patient deficient in endogenous testosterone levels, methods for male contraception and methods for treating a disease or symptom associated with deficient endogenous levels of testosterone in a man, by intramuscularly administering testosterone esters in a vehicle.
Claims25
A method of providing prolonged physiologically acceptable steady state serum testosterone levels in a patient deficient in endogenous testosterone levels comprising intramuscularly administering a maintenance dose of a composition comprising testosterone undecanoate and a vehicle consisting essentially of castor oil and a co-solvent once every 10-14 weeks following 2-4 initial doses of said composition, each initial dose being administered at an interval of 4-8 weeks.
A method of treating a disease or symptom associated with deficient endogenous levels of testosterone in a man, comprising administering by intramuscular injection a composition comprising testosterone undecanoate (TU) and a vehicle consisting essentially of castor oil and a co-solvent, the castor oil being present in the vehicle at a concentration of less than 40 percent by volume, the method further comprising:
- (i) an initial phase comprising 2 initial intramuscular injections of a dose of TU at an interval of 4 weeks between injections, each dose including 500 mg to 1000 mg of TU, and
- (ii) a maintenance phase comprising subsequent intramuscular injections of a dose of TU at an interval of 10 weeks between injections, each dose including 500 mg to 1000 mg of TU.
A method for male contraception in a man comprising intramuscularly administering to the man a maintenance dose of a composition comprising testosterone undecanoate and a vehicle consisting essentially of castor oil and a co-solvent once every 10-14 weeks following 2-4 initial doses of said composition, each initial dose being administered at an interval of 4-8 weeks.
Dependencies are inferred from the claim text.