Evaluation of Testosterone Nasal Gel in Hypogonadal Boys

• Status: Unknown status
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acerus Biopharma Inc.; Acerus Pharmaceuticals Corporation
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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.