Evaluation of Testosterone Nasal Gel in Hypogonadal Boys

NCT03345797 | Terminated Phase 1

• 1 other identifier: NAT-2017-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hypogonadism

Keywords

Paediatric

Outcome Measures

Primary Outcomes (4)

• Maximum plasma concentration (Cmax)

  Cmax for serum testosterone, serum DHT and serum estradiol

  48 hours (approx)

• Area under the curve (AUC)

  AUC for serum testosterone, serum DHT and serum estradiol

  48 hours (approx)

• Minimum serum concentration (Cmin)

  Cmin for serum testosterone, serum DHT and serum estradiol

  48 hours (approx)

• Time to reach maximum plasma concentration (tmax)

  tmax for serum testosterone, serum DHT and serum estradiol

  48 hours (approx)

Secondary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (Safety)

  5 days

• Incidence of Treatment-Emergent Adverse Events (Tolerability)

  48 hours (approx)

Study Arms (2)

Naive patients - ARM 1

EXPERIMENTAL

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

Drug: Testosterone Nasal Gel [Natesto]

Non-naive patients - ARM 2

EXPERIMENTAL

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

Drug: Testosterone Nasal Gel [Natesto]

Interventions

Testosterone Nasal Gel [Natesto] DRUG

nasal gel containing 4.5% w/w testosterone

Naive patients - ARM 1; Non-naive patients - ARM 2

Eligibility Criteria

• Age: 12 Years - 17 Years
• Gender Eligibility Details: hypogonadal boys
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Hypogonadal boys;
• Chronological age 12 to \<18 years;
• No prior exposure to TRT;
• Prepubertal
• Parent/guardian and patient able to understand and provide signed informed consent;
• Hypogonadal boys with a bone age of ≥13 years (a historical value within the last 12 months will be acceptable);
• Chronological age 12 to \<18 years;
• Taking an existing TRT treatment dose;
• Tanner Stage ≥3
• Parent/guardian and patient able to understand and provide signed informed consent;

You may not qualify if:

• 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:
• Any active allergic condition or presentation of symptoms including allergic rhinitis;
• An upper respiratory tract infection;
• 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;
• In the opinion of the Investigator, significant intercurrent disease of any type, in particular liver, kidney, heart disease, stroke, or psychiatric illness;
• 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;
• 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;
• History of severe adverse drug reactions to testosterone therapies;
• Current treatment with other androgens (e.g., dehydroepiandrosterone \[DHEA\]), anabolic steroids, or other sex hormones;
• Treatment with estrogens, gonadotropin-releasing hormone (GnRH) agonists, or growth hormone within the previous 12 months;
• Treatment with drugs that interfere with the metabolism of testosterone, such as anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, or testolactone;
• Diabetes mellitus;
• Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study.

Sponsors & Collaborators

• Acerus Biopharma Inc.: lead

Study Sites (3)

University of Glasgow, Royal Hospital for Children

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Cambridge University Hospital's NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Alder Hey Children's Hospital

Liverpool, L14 5AB, United Kingdom

Location

MeSH Terms

Conditions

Hypogonadism

Interventions

Natesto

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Syed Faisal Ahmed, MD

  Royal Hospital for Children, U. of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: dual arm: naïve vs TRT experienced

Study Record Dates

• First Submitted: October 10, 2017
• First Posted: November 17, 2017
• Study Start: March 1, 2018
• Primary Completion: April 11, 2020
• Study Completion: April 11, 2022
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)