Efficacy of Nasal Testosterone Gel (Natesto®) Stratified by Baseline Endogenous Testosterone Levels

• DOI: 10.1210/js.2019-00183
• Publication Date: 2019-06-26T13:00:23Z
• Authors: Matthew A Gronski; Ethan D Grober; Irving S Gottesman; Ross W Ormsby; Nathan Bryson
• Keywords: 03 medical and health sciences; 0302 clinical medicine; Clinical Research Articles

Pharmacokinetic and efficacy data from a phase 3 testosterone nasal gel (TNG) study were stratified by baseline endogenous level in patients with deficiency. Total (TT), LH, FSH levels, as well erectile function, mood, lean body mass for each group compared. In subset of very low levels (<100 ng/dL), we investigated whether TNG is suitable treatment option.Patients deficiency (serum TT <300 ng/dL) treated months, followed safety extension periods 90 and/or 180 days. parameters calculated serum hormone on days 30 90, along measurements, which analyzed comparison values. Baseline predose values used patient stratification.Prestudy concentrations correlated. The maximal concentration was nearly identical across all cohorts at whereas the average over 24 hours had slight positive dependence relative to levels. LH remained normal range but decreased more higher starting These findings indicate that works an active hypothalamic-pituitary-gonadal axis responds dose throughout period. Patients lowest received maximum exposure impact dose. severe similar improvements remainder population.All testosterone-deficient successfully TNG.