Aytu BioScience (OTCQX:AYTU) announces the summary of findings that demonstrated significant clinical improvements in erectile function and mood in hypogonadal men treated with Natesto nasal testosterone gel (NTG). Natesto, its FDA-approved nasal testosterone gel launched in late July.
The 90-day multi-center Phase 3 study conducted in the U.S. investigated the safety and efficacy of NTG administered intranasally to 306 men.
Treatment with Natesto led to statistically significant improvements in each of the 5 domains of erectile function. Most of the benefit was evident by day 30. Similar to erectile function, NTG produced clinically and statistically significant improvements in mood by day 30, with continued improvements seen through study completion.
Male hypogonadism is a clinical syndrome resulting from failure of the testes to produce physiologic levels of testosterone due to disruption of the hypothalamic-pituitary-gonadal axis and is often characterized by mood disturbances, reduced energy levels, and impaired sexual function.