Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT05417035
Status:
COMPLETED
Last Update Posted:
2022-06-14
First Post:
2022-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-06-06', 'releaseDate': '2025-05-22'}, {'resetDate': '2025-06-25', 'releaseDate': '2025-06-09'}], 'estimatedResultsFirstSubmitDate': '2025-05-22'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011628', 'term': 'Puberty, Delayed'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010792', 'term': 'testosterone undecanoate'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-01-30', 'size': 905232, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-18T11:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective open clinical study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-09', 'studyFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2022-06-09', 'lastUpdatePostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Testicular Volume 8ml', 'timeFrame': '12 months after induction', 'description': 'Evaluation by palpating the testicles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Puberty Delayed']}, 'referencesModule': {'references': [{'pmid': '37124726', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Only for induction of puberty for boys (testosterone) For girls estradiol is used', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Signed informed consent\n\n * Two morning testosterone values (07.30-09.00) of 1-3 nmol/L and at start \\< 4 mmol/L ¹\n * Testicular volume 4-6 mL bilaterally²\n\nExclusion Criteria:\n\n* • Growth spurt\n\n * Untreated hypothyroidism, celiac disease or steroid medication\n * Training doses \\> 10 hours a week\n * Use of anabolic steroids or other drugs'}, 'identificationModule': {'nctId': 'NCT05417035', 'briefTitle': 'Pubertal Replacement In Boys Study Nebido and Testoviron Depot Treatment', 'organization': {'class': 'OTHER', 'fullName': 'NU-Hospital Organization, Sweden'}, 'officialTitle': 'Pubertal Replacement In Boys Study Pubertal Induction in Boys With Delayed Puberty: Comparison Between Testosterone Enanthate and Testosterone Undecanoate Treatment.', 'orgStudyIdInfo': {'id': 'EudraCT nr 2012-002337-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nebido', 'description': 'i.m 250 mg/3months 2 injectionjs', 'interventionNames': ['Drug: Nebido']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Testoviron Depot', 'description': 'i.m75mg/month 6 injections', 'interventionNames': ['Drug: Nebido']}], 'interventions': [{'name': 'Nebido', 'type': 'DRUG', 'otherNames': ['Testosteroneundecanoate'], 'description': 'To evaluate if traditional treatment induces puberty similary to newer treatment', 'armGroupLabels': ['Nebido', 'Testoviron Depot']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'timeFrame': 'Vill be shared after study published', 'ipdSharing': 'YES', 'description': 'After the study is completed and published', 'accessCriteria': 'After the study has been published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NU-Hospital Organization, Sweden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Paediatrician', 'investigatorFullName': 'Martin Österbrand', 'investigatorAffiliation': 'NU-Hospital Organization, Sweden'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-05-22', 'type': 'RELEASE'}, {'date': '2025-06-06', 'type': 'RESET'}, {'date': '2025-06-09', 'type': 'RELEASE'}, {'date': '2025-06-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Martin Österbrand, Paediatrician, NU-Hospital Organization, Sweden'}}}}