Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment

Not Applicable

Completed

• Conditions: Puberty Delayed
• Interventions: Drug: Nebido

• Registration Number: NCT05417035
• Lead Sponsor: NU-Hospital Organization, Sweden

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 Timeline

• Study Start: 2014-06-01
• Primary Completion: 2019-08-01
• Study Completion: 2020-08-01
• Study First Submitted: 2022-03-28
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-09
• Last Update Submitted: 2022-06-09
• Study First Posted: 2022-06-14
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

• • Signed informed consent

  • Two morning testosterone values (07.30-09.00) of 1-3 nmol/L and at start < 4 mmol/L ¹
  • Testicular volume 4-6 mL bilaterally²

Exclusion Criteria

• • Growth spurt

  • Untreated hypothyroidism, celiac disease or steroid medication
  • Training doses > 10 hours a week
  • Use of anabolic steroids or other drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebido	Nebido	i.m 250 mg/3months 2 injectionjs
Testoviron Depot	Nebido	i.m75mg/month 6 injections

Primary Outcome Measures

Name	Time	Method
Testicular Volume 8ml	12 months after induction	Evaluation by palpating the testicles