Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment

NCT ID: NCT05417035

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-01
• Study Completion Date: 2020-08-01

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).

Conditions

Puberty Delayed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nebido

i.m 250 mg/3months 2 injectionjs

Group Type: EXPERIMENTAL

Nebido

Intervention Type: DRUG

To evaluate if traditional treatment induces puberty similary to newer treatment

Testoviron Depot

i.m75mg/month 6 injections

Group Type: ACTIVE_COMPARATOR

Nebido

Intervention Type: DRUG

To evaluate if traditional treatment induces puberty similary to newer treatment

Interventions

Nebido

To evaluate if traditional treatment induces puberty similary to newer treatment

Intervention Type: DRUG

Other Intervention Names

Testosteroneundecanoate

Eligibility Criteria

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

NU-Hospital Organization, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Martin Österbrand

Paediatrician

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Osterbrand M, Fors H, Norjavaara E. Pharmacological treatment for pubertal progression in boys with delayed or slow progression of puberty: A small-scale randomized study with testosterone enanthate and testosterone undecanoate treatment. Front Endocrinol (Lausanne). 2023 Apr 14;14:1158219. doi: 10.3389/fendo.2023.1158219. eCollection 2023.

Reference Type: DERIVED

PMID: 37124726 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

EudraCT nr 2012-002337-11

Identifier Type: -

Identifier Source: org_study_id