Evaluation of Testosterone Nasal Gel in Hypogonadal Boys

NCT ID: NCT03345797

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2022-04-11

Brief Summary

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

Detailed 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.

Conditions

Hypogonadism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Naive patients - ARM 1

TRT naïve subjects, Tanner Stage of 0, receiving Testosterone Nasal Gel \[Natesto\] - Single dose of 5.5 mg Natesto on Day 1 and a single dose of 11 mg Natesto on Day 2

Group Type: EXPERIMENTAL

Testosterone Nasal Gel [Natesto]

Intervention Type: DRUG

nasal gel containing 4.5% w/w testosterone

Non-naive patients - ARM 2

TRT non-naïve subjects (have had prior testosterone treatment), Tanner Stage \>/= 3, receiving Testosterone Nasal Gel \[Natesto\] - Single dose of 11 mg Natesto on Day 1. On Day 2, 11 mg dose of Natesto in the morning and 11 mg dose of Natesto 12 hours later

Group Type: EXPERIMENTAL

Testosterone Nasal Gel [Natesto]

Intervention Type: DRUG

nasal gel containing 4.5% w/w testosterone

Interventions

Testosterone Nasal Gel [Natesto]

nasal gel containing 4.5% w/w testosterone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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;

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Acerus Biopharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Syed Faisal Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Hospital for Children, U. of Glasgow

Locations

University of Glasgow, Royal Hospital for Children

Glasgow, Scotland, United Kingdom

Cambridge University Hospital's NHS Foundation Trust

Cambridge, , United Kingdom

Alder Hey Children's Hospital

Liverpool, , United Kingdom

Countries

United Kingdom

Other Identifiers

NAT-2017-01

Identifier Type: -

Identifier Source: org_study_id