Last updated on July 2019

Evaluation of Testosterone Nasal Gel in Hypogonadal Boys


Brief description of study

PK study to evaluate serum levels of testosterone post nasal delivery in two cohorts of hypogonadal boys.

Detailed Study Description

ARM 1 - 10 prepubertal, 12-17 years old boys with no prior exposure to TRT will receive single dose of 5.5 mg on day one and single dose of 11 mg on day 2 with repeat blood draws to assess serum levels of testosterone and metabolites.

ARM 2 - 10 Tanner Stage 3, 12-17 years old boys on TRT with bone age >= 13 years will receive single dose of 11 mg on day one, and single dose of 11 mg in the morning and a second 11 mg dose in the afternoon on day 2 with repeat blood draws to assess serum levels of testosterone and metabolites.

Clinical Study Identifier: NCT03345797

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