The present invention provides stable pharmaceutical compositions, comprising a pharmaceutically effective amount of
testosterone or a pharmaceutically acceptable ester thereof, a pharmaceutically acceptable oil vehicle, and a stabilizing amount of
benzyl alcohol, for example, about 1% to 3% weight / volume of
benzyl alcohol. The present invention also provides a process for stabilizing
testosterone-containing pharmaceutical compositions by
ageing them at a temperature of about 20° C. to about 60° C. for at least 48 hours, e.g., prior to secondary packing and labeling. These compositions were stable over the
shelf life of the product, without exhibiting
crystal formation, even upon storing at temperatures of about 2° C. to about 8° C. Other aspects of the invention relate to methods for making such pharmaceutical compositions, and methods of using such pharmaceutical compositions for
hormone replacement therapy, e.g., in a
male patient having a condition associated with symptoms of deficiency or absence of endogenous
testosterone.