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Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment

Primary Purpose

Puberty Delayed

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Nebido

About this trial

This is an interventional treatment trial for Puberty Delayed

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nebido

Testoviron Depot

Arm Description

i.m 250 mg/3months 2 injectionjs

i.m75mg/month 6 injections

Outcomes

Primary Outcome Measures

Testicular Volume 8ml

Evaluation by palpating the testicles

Secondary Outcome Measures

Full Information

NCT ID

NCT05417035

First Posted

March 28, 2022

Last Updated

June 9, 2022

Sponsor

NU-Hospital Organization, Sweden

1. Study Identification

Unique Protocol Identification Number

NCT05417035

Brief Title

Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment

Official Title

Pubertal Replacement In Boys Study Pubertal Induction in Boys With Delayed Puberty: Comparison Between Testosterone Enanthate and Testosterone Undecanoate Treatment.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

June 1, 2014 (Actual)

Primary Completion Date

August 1, 2019 (Actual)

Study Completion Date

August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

NU-Hospital Organization, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Puberty Delayed

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

prospective open clinical study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nebido

Arm Type

Experimental

Arm Description

i.m 250 mg/3months 2 injectionjs

Arm Title

Testoviron Depot

Arm Type

Active Comparator

Arm Description

i.m75mg/month 6 injections

Intervention Type

Drug

Intervention Name(s)

Nebido

Other Intervention Name(s)

Testosteroneundecanoate

Intervention Description

To evaluate if traditional treatment induces puberty similary to newer treatment

Primary Outcome Measure Information:

Title

Testicular Volume 8ml

Description

Evaluation by palpating the testicles

Time Frame

12 months after induction

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Only for induction of puberty for boys (testosterone) For girls estradiol is used

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

After the study is completed and published

IPD Sharing Time Frame

Vill be shared after study published

IPD Sharing Access Criteria

After the study has been published

Learn more about this trial

Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment

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