The present invention relates to intranasal
testosterone gels for the
controlled release of
testosterone into the
systemic circulation of males and females for providing constant effective
testosterone blood levels, without inducing undesired testosterone spike in blood levels, following pernasal administration. The intranasal testosterone gels of the present invention are safe, convenient to use, well tolerated, stable and easily and reproducibly manufactured on scale up. Moreover, because supra- normal and sub-normal testosterone blood levels are believed to be essentially kept to a minimum or avoided and the testosterone serum levels are believed to remain essentially constant during
dose life, i.e., the intranasal testosterone gels of the present invention mimic or restore testosterone blood levels to normal physiologic daily rhythmic testosterone levels, the novel intranasal testosterone gels of the present invention are uniquely suited for testosterone replacement or supplemental therapy and effective for treating males diagnosed with, for example, male
testosterone deficiency, such as, low sexual
libido, low sexual drive, low sexual activity,
low fertility, low
spermatogenesis, aspermatogenesis, depression and / or hypogonadism, and females who are diagnosed with, for example,
female sexual dysfunction, such as, low sexual
libido, low sexual drive, low sexual activity, low amygdala reactivity, low
sexual stimulation, hypoactive sexual desire
disease ("HSDD"), female
sexual arousal disorder and / or anorgasmia. The present invention also relates to methods and pre- filled multi-
dose airless applicator systems for pernasal administration of the nasal testosterone gels of the present invention.