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

ABSTRACT:

Objective

Pharmacokinetic and efficacy data from a phase 3 testosterone nasal gel (TNG) study were stratified by baseline endogenous testosterone level in patients with testosterone deficiency. Total testosterone (TT), LH, and FSH levels, as well as erectile function, mood, and lean body mass for each group were compared. In a subset of patients with very low baseline endogenous testosterone levels (<100 ng/dL), we investigated whether TNG is a suitable treatment option.

Materials and methods

Patients with testosterone deficiency (serum TT <300 ng/dL) were treated with TNG for 3 months, followed by safety extension periods of 90 and/or 180 days. Pharmacokinetic parameters were calculated from serum hormone levels on days 30 and 90, along with efficacy measurements, which wer

SUBMITTER: Gronski MA 

PROVIDER: S-EPMC6694041 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature