Puberty DelayedNCT05417035
Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment
A study testing Nebido in people with Puberty Delayed, run by NU-Hospital Organization, Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Puberty Delayed
- What is being tested?
- Nebido
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • Growth spurt
- Untreated hypothyroidism, celiac disease or steroid medication
- Training doses > 10 hours a week
- Use of anabolic steroids or other drugs
About this study
Official title: Pubertal Replacement In Boys Study Pubertal Induction in Boys With Delayed Puberty: Comparison Between Testosterone Enanthate and Testosterone Undecanoate Treatment.
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.
Read the 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
- Being tested
- Nebido
- Medical subject headings
- Puberty, Delayed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebidoDrug
Also called Testosteroneundecanoate
To evaluate if traditional treatment induces puberty similary to newer treatment
| Study group | Role | What they receive |
|---|---|---|
| Nebido | Experimental | i.m 250 mg/3months 2 injectionjs Receives: Drug: Nebido |
| Testoviron Depot | Active comparator | i.m75mg/month 6 injections Receives: Drug: Nebido |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testicular Volume 8ml
Evaluation by palpating the testicles
Measured: 12 months after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Jun 2014
- Primary completion1 Aug 2019
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Puberty DelayedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective open clinical study
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- NU-Hospital Organization, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Österbrand, NU-Hospital Organization, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417035
- Sponsor's protocol ID
- EudraCT nr 2012-002337-11
- Status last verified
- Jun 2022
- First submitted
- 28 Mar 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed and published
Publications
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.
PubMed 37124726
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pubertal Replacement In Boys Study Pubertal Induction in Boys With Delayed Puberty: Comparison Between Testosterone Enanthate and Testosterone Undecanoate Treatment.
- ClinicalTrials.gov ID
- NCT05417035
- Acronym / sponsor ID
- EudraCT nr 2012-002337-11
- Conditions
- Puberty Delayed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- NU-Hospital Organization, SwedenUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective open clinical study
| Arm | Type | Receives |
|---|---|---|
| Nebido | Experimental | Drug: Nebidoi.m 250 mg/3months 2 injectionjs |
| Testoviron Depot | Active comparator | Drug: Nebidoi.m75mg/month 6 injections |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- • Signed informed consent
Key exclusion criteria (4 listed)
- • Growth spurt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NebidoAlso: TestosteroneundecanoateTo evaluate if traditional treatment induces puberty similary to newer treatment | Drug | Nebido, Testoviron Depot |
Primary outcome
Testicular Volume 8ml
Time frame: 12 months after induction
Evaluation by palpating the testicles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Derived from this study: PubMed 37124726Osterbrand 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.
- Individual participant dataSharing planned: Yes. After the study is completed and published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nebido in people with Puberty Delayed, run by NU-Hospital Organization, Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testicular Volume 8ml (time frame: 12 months after induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05417035, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.