Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT05417035
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2022-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment
Sponsor:
NU-Hospital Organization, Sweden
Organization:
Study Overview
Official Title:
Pubertal Replacement In Boys Study Pubertal Induction in Boys With Delayed Puberty: Comparison Between Testosterone Enanthate and Testosterone Undecanoate Treatment.
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this prospective open clinical study, Pubertal Replacement in Boys Study (PRIBS), boys 14-16 years with delayed puberty in terms of slow pubertal progression, were randomized to SoC treatment with TE: Testostoviron depot® 75 mg intramuscularly (i.m) / month (6 injections), or low dose TU: Nebido® 250mg i.m. / 3 months (2 injections). Our goal was to implement a study similar to clinical routine.
Detailed Description:
Boys 14-16 years with pubertal delay were randomized to standard treatment with TE (Testosterone enanthat 75mg /month 6 injections)or newer treatment TU(Testosterone Undecanooat 250mg 2 injections 3 months apart) for pubertal induction. Our study PRIBS (pubertal replacement in boys study) was academically sponsored, monitored and approved by the medical products agency in Sweden. Between 2014 -08 and 2019-07 27 boys were randomized to treatment with TE (12 boys) or TU (15 boys). Testosterone levels were measured twice before study start and after 2,7,30,60,90,180 and 365 days. Boys with delayed puberty \> 14 years with morning testosterone levels 0,5 - 3 Nmol/L and testicular volume ≤ 6 mL were included.Primary Outcome was testicular enlargement ≥ 8mL after 12 months. The new treatment was considered clinically similar if the treatment result were in the 80-125% interwall of the traditional group. Fishers exact chi square test was used for this analysis. Our intention was to recruit 20 boys in each armInformed consent was signed before study start by parents and assent by the boys. PRIBS was approved by the regional ethic committee 2012-09-14 Dnr 506-12 and approved by Union Drug Regulating Authorities Clinical Trials Database EudraCT nr 2012-002337-11 and the Swedish drug authorities (Läkemedelsverket) All study personal was trained in ICH GCP (good clinical practice).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: