Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-04 @ 7:43 PM
Study NCT ID:
NCT01797718
Status:
COMPLETED
Last Update Posted:
2018-02-06
First Post:
2013-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-04-25', 'releaseDate': '2022-02-23'}, {'resetDate': '2023-02-02', 'releaseDate': '2022-05-04'}, {'resetDate': '2023-12-04', 'releaseDate': '2023-02-27'}], 'estimatedResultsFirstSubmitDate': '2022-02-23'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-05', 'studyFirstSubmitDate': '2013-02-18', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'testicular volume', 'timeFrame': 'one year', 'description': 'Testes will be measured with a ruler to the nearest millimeter and volume will be calculated at 0, 6, and 12 mo'}, {'measure': 'clinical and biochemical measures of pubertal progression', 'timeFrame': 'one year', 'description': 'Activity of the hypothalamic-pituitary-gonadal axis, evaluated by\n\n* genital and pubic hair stage of puberty according to Tanner;\n* growth velocity (cm/yr);\n* basal and gonadotropin-releasing hormone (GnRH)-stimulated gonadotropin levels;\n* urinary luteinizing hormone levels;\n* testosterone;\n* inhibin B;\n* anti-mullerian hormone (AMH)'}], 'secondaryOutcomes': [{'measure': 'Bone health', 'timeFrame': 'one year', 'description': 'Several endpoints related to bone health'}, {'measure': 'Psychosocial well-being', 'timeFrame': 'one year', 'description': 'Psycho-social well-being will assessed with questionnaires.'}, {'measure': 'Puberty-related metabolical and clinical changes', 'timeFrame': 'one year', 'description': 'Biochemical and metabolical changes will be compared btw testosterone and letrozole treatment groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Puberty', 'Constitutional', 'Delay', 'Letrozole', 'Testosterone'], 'conditions': ['Constitutional Delay of Growth and Puberty']}, 'referencesModule': {'references': [{'pmid': '40796279', 'type': 'DERIVED', 'citation': 'Varimo T, Miettinen PJ, Huopio H, Rikkonen T, Voutilainen R, Tenhola S, Raivio T, Hero M. Impact of aromatase inhibition on bone mineral density and structure: a randomized controlled trial in boys with delayed puberty. Eur J Endocrinol. 2025 Jul 31;193(2):289-296. doi: 10.1093/ejendo/lvaf160.'}, {'pmid': '36518253', 'type': 'DERIVED', 'citation': 'Kariola L, Varimo T, Huopio H, Tenhola S, Voutilainen R, Kosola S, Toppari J, Sintonen H, Miettinen PJ, Raivio T, Hero M. Health-related quality of life in boys with constitutional delay of growth and puberty. Front Endocrinol (Lausanne). 2022 Nov 25;13:1028828. doi: 10.3389/fendo.2022.1028828. eCollection 2022.'}, {'pmid': '34596269', 'type': 'DERIVED', 'citation': 'Huttunen H, Varimo T, Huopio H, Voutilainen R, Tenhola S, Miettinen PJ, Raivio T, Hero M. Serum testosterone and oestradiol predict the growth response during puberty promoting treatment. Clin Endocrinol (Oxf). 2022 Feb;96(2):220-226. doi: 10.1111/cen.14605. Epub 2021 Oct 1.'}, {'pmid': '31958337', 'type': 'DERIVED', 'citation': 'Kohva E, Varimo T, Huopio H, Tenhola S, Voutilainen R, Toppari J, Miettinen PJ, Vaaralahti K, Viinamaki J, Backman JT, Hero M, Raivio T. Anti-Mullerian hormone and letrozole levels in boys with constitutional delay of growth and puberty treated with letrozole or testosterone. Hum Reprod. 2020 Feb 29;35(2):257-264. doi: 10.1093/humrep/dez231.'}, {'pmid': '30612946', 'type': 'DERIVED', 'citation': 'Varimo T, Huopio H, Kariola L, Tenhola S, Voutilainen R, Toppari J, Toiviainen-Salo S, Hamalainen E, Pulkkinen MA, Laaperi M, Tarkkanen A, Vaaralahti K, Miettinen PJ, Hero M, Raivio T. Letrozole versus testosterone for promotion of endogenous puberty in boys with constitutional delay of growth and puberty: a randomised controlled phase 3 trial. Lancet Child Adolesc Health. 2019 Feb;3(2):109-120. doi: 10.1016/S2352-4642(18)30377-8. Epub 2019 Jan 4.'}]}, 'descriptionModule': {'briefSummary': 'Boys with constitutional delay of growth and puberty (CDGP) should be offered evidence-based effective and safe treatment option. This study compares the effects of low-dose testosterone and aromatase inhibitor letrozole on pubertal progression. The hypothesis is that, in boys CDGP showing earliest signs of puberty, peroral letrozole (2.5 mg/d for 6 mo) induces faster biochemical and clinical progression of puberty as compared to low-dose intramuscular testosterone Rx (\\~1mg/kg/mo for 6 mo). In addition, 10 or more boys who select watchful waiting instead of medication will provide background data on the natural progression of CDGP, and their data will not be used in primary statistical comparisons.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Constitutional delay of growth and puberty\n* Age 14 years or more\n* mean testicular volume 2.5 ml or more and less than 4 ml\n* serum testosterone level less than 5 nM OR\n\nas above, but serum testosterone 1 nM or more with normal DHEAS level, even if the mean testicular volume is less than 2.5 ml OR\n\nas above, but tanner stage G2 and testosterone level less than 3 nM\n\nExclusion Criteria:\n\n* Chronic diseases\n* Primary or secondary hypogonadism\n* Chromosomal anomalies\n* Chronic medication that potentially adversely affects bone mineralization (excluding inhaled corticosteroid treatment)'}, 'identificationModule': {'nctId': 'NCT01797718', 'acronym': 'CDGP', 'briefTitle': 'Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'Constitutional Delay of Growth and Puberty: Towards Evidence-based Treatment', 'orgStudyIdInfo': {'id': 'EudraCT:2012-002477-59'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Testosterone', 'description': '\\~1mg/kg every 4 weeks for 6 months', 'interventionNames': ['Drug: Testosterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Letrozole', 'description': '2.5mg daily for 6 months', 'interventionNames': ['Drug: Letrozole']}], 'interventions': [{'name': 'Testosterone', 'type': 'DRUG', 'otherNames': ['Sustanon 250'], 'description': '1mg/kg every 4 weeks for 6 months', 'armGroupLabels': ['Testosterone']}, {'name': 'Letrozole', 'type': 'DRUG', 'otherNames': ['Letrozole Bluefish', 'Letrozole Orion', 'Letrozole Accord', 'Letrozole Sandoz', 'Femar'], 'description': '2.5mg daily for 6 months. Safety criteria: if testosterone level is above 30nM at 3 months, the dosage is reduced to 2.5mg every other day', 'armGroupLabels': ['Letrozole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Kotka', 'country': 'Finland', 'facility': 'Kotka Central Hospital', 'geoPoint': {'lat': 60.4664, 'lon': 26.94582}}, {'zip': '70211', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Central Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Central Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Taneli Raivio, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Matti Hero, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Tero Varimo, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Päivi Miettinen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Helsinki University Central Hospital'}, {'name': 'Jorma Toppari, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Turku'}, {'name': 'Hanna Huopio, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kuopio University Central Hospital'}, {'name': 'Sirpa Tenhola, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kymeenlaakso Central Hospital'}, {'name': 'Raimo Voutilainen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kuopio University Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation for Paediatric Research, Finland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Tero Varimo, MD, PhD', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-02-23', 'type': 'RELEASE'}, {'date': '2022-04-25', 'type': 'RESET'}, {'date': '2022-05-04', 'type': 'RELEASE'}, {'date': '2023-02-02', 'type': 'RESET'}, {'date': '2023-02-27', 'type': 'RELEASE'}, {'date': '2023-12-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tero Varimo, MD, PhD, MD, Helsinki University Central Hospital'}}}}