evaluation of testosterone nasal gel in hypogonadal boys

Conditions: Hypogonadism

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

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.

Eligibility criteria:
inclusion criteria: arm 1 (naïve patients): participants who meet all of the following inclusion criteria will be eligible for participation in the study: 1. hypogonadal boys; 2. chronological age 12 to \<18 years; 3. no prior exposure to trt; 4. prepubertal 5. parent/guardian and patient able to understand and provide signed informed consent; arm 2 (non-naïve patients): participants who meet all of the following inclusion criteria will be eligible for participation in the study: 1. hypogonadal boys with a bone age of ≥13 years (a historical value within the last 12 months will be acceptable); 2. chronological age 12 to \<18 years; 3. taking an existing trt treatment dose; 4. tanner stage ≥3 5. parent/guardian and patient able to understand and provide signed informed consent; 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: 1. any active allergic condition or presentation of symptoms including allergic rhinitis; 2. an upper respiratory tract infection; 3. use of any form of intranasal medication delivery other than periodic short-term (less than 3 days) use of sympathomimetic decongestants, within the last 3 months; 4. in the opinion of the investigator, significant intercurrent disease of any type, in particular liver, kidney, heart disease, stroke, or psychiatric illness; 5. history of pituitary or hypothalamic tumors or history of any malignancy excluding basal cell or squamous cell carcinoma of the skin curatively treated by surgery; 6. history of nasal disorders, nasal or sinus surgery, nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum surgery, mucosal inflammatory disorders, specifically sjogren's syndrome; 7. history of severe adverse drug reactions to testosterone therapies; 8. current treatment with other androgens (e.g., dehydroepiandrosterone \[dhea\]), anabolic steroids, or other sex hormones; 9. treatment with estrogens, gonadotropin-releasing hormone (gnrh) agonists, or growth hormone within the previous 12 months; 10. treatment with drugs that interfere with the metabolism of testosterone, such as anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, or testolactone; 11. diabetes mellitus; 12. participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study.

Keywords: paediatric