Status:
TERMINATED
Evaluation of Testosterone Nasal Gel in Hypogonadal Boys
Lead Sponsor:
Acerus Biopharma Inc.
Conditions:
Hypogonadism
Eligibility:
MALE
12-17 years
Phase:
PHASE1
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 level...
Eligibility Criteria
Inclusion
- ARM 1 (naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
- 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;
- ARM 2 (non-naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study:
- 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;
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03345797
Start Date
March 1 2018
End Date
April 11 2022
Last Update
October 26 2023
Active Locations (3)
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1
University of Glasgow, Royal Hospital for Children
Glasgow, Scotland, United Kingdom, G51 4TF
2
Cambridge University Hospital's NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
3
Alder Hey Children's Hospital
Liverpool, United Kingdom, L14 5AB