Status and phase
Conditions
Treatments
About
PK study to evaluate serum levels of testosterone post nasal delivery in two cohorts of hypogonadal boys.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
ARM 1 (naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
ARM 2 (non-naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
Exclusion criteria
ARM 1 (naïve patients) AND ARM 2 (non-naïve patients): Participants who meet any of the following criteria will be excluded from participation in the study:
Primary purpose
Allocation
Interventional model
Masking
8 participants in 2 patient groups
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Central trial contact
Matthew Gronski, Ph.D.; Nathan Bryson, Ph.D.
Data sourced from clinicaltrials.gov
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