Trials / Terminated
TerminatedNCT03345797
Evaluation of Testosterone Nasal Gel in Hypogonadal Boys
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Acerus Biopharma Inc. · Industry
- Sex
- Male
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Testosterone Nasal Gel [Natesto] | nasal gel containing 4.5% w/w testosterone |
Timeline
- Start date
- 2018-03-01
- Primary completion
- 2020-04-11
- Completion
- 2022-04-11
- First posted
- 2017-11-17
- Last updated
- 2023-10-26
Locations
3 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03345797. Inclusion in this directory is not an endorsement.