Evaluation of Testosterone Nasal Gel in Hypogonadal Boys

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Hypogonadism

Clinical Trial Details

NCT number	NCT03345797
Study type	Interventional
Source	Acerus Pharmaceuticals Corporation
Contact
Status	Terminated
Phase	Phase 1
Start date	March 1, 2018
Completion date	April 11, 2022

View Details

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