Evaluation of Testosterone Nasal Gel in Hypogonadal Boys

Launched by ACERUS BIOPHARMA INC. · Nov 14, 2017

Keywords

ClinConnect Summary

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.

Gender

MALE

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.