Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment
1 other identifier
interventional
27
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 28, 2022
CompletedFirst Posted
Study publicly available on registry
June 14, 2022
CompletedJune 14, 2022
June 1, 2022
5.2 years
March 28, 2022
June 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Testicular Volume 8ml
Evaluation by palpating the testicles
12 months after induction
Study Arms (2)
Nebido
EXPERIMENTALi.m 250 mg/3months 2 injectionjs
Testoviron Depot
ACTIVE COMPARATORi.m75mg/month 6 injections
Interventions
To evaluate if traditional treatment induces puberty similary to newer treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Growth spurt
- Untreated hypothyroidism, celiac disease or steroid medication
- Training doses \> 10 hours a week
- Use of anabolic steroids or other drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 37124726DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Paediatrician
Study Record Dates
First Submitted
March 28, 2022
First Posted
June 14, 2022
Study Start
June 1, 2014
Primary Completion
August 1, 2019
Study Completion
August 1, 2020
Last Updated
June 14, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Vill be shared after study published
- Access Criteria
- After the study has been published
After the study is completed and published