A multicenter, open label, variable dose, two arm pilot paediatric phase 1 PK study to evaluate testosterone nasal gel (4.5% w/w) in hypogonadal boys

Phase 1

• Conditions: Primary and secondary hypogonadism; MedDRA version: 20.0Level: PTClassification code 10052649Term: Primary hypogonadismSystem Organ Class: 10014698 - Endocrine disorders; MedDRA version: 20.0Level: PTClassification code 10059594Term: Secondary hypogonadismSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Body processes [G] - Biological Phenomena [G16]

• Registration Number: EUCTR2017-001012-11-GB
• Lead Sponsor: Acerus Biopharma Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-11
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 20

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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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. Any active malignancy, however a prior history of a malignancy which has been in remission for 12 months will be allowed;
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 drugs that interfere with the metabolism of testosterone, such as anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, or testolactone;
10. Diabetes mellitus;
11. Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified