Evaluation of Testosterone Nasal Gel in Hypogonadal Boys

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.