Aytu BioScience’s (NASDAQ:AYTU) study titled, Efficacy of Nasal Testosterone Gel (Natesto) Stratified by Baseline Endogenous Testosterone Levels, achieves similar symptom improvement, regardless of the degree of patients’ testosterone deficiency, while maintaining function of the Hypothalamic-Pituitary-Gonadal (HPG) axis in hypogonadal men.
The Phase 3 study enrolled 306 patients, who were treated with Natesto for up to one year. Each dose of Natesto resulted in a short-term return of testosterone to the upper normal range (800 ng/dL) irrespective of how low the patient’s baseline testosterone was prior to the study.
A mean average serum testosterone level of 295 ng/dL was achieved, in patients with the lowest baseline testosterone level.
Statistically significant improvements in symptom relief (erectile function, mood and lean body mass) were observed in these patients.
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