Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-03-11 @ 4:13 PM
Study NCT ID:
NCT00029159
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2002-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014424', 'term': 'Turner Syndrome'}], 'ancestors': [{'id': 'D006059', 'term': 'Gonadal Dysgenesis'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D058533', 'term': 'Sex Chromosome Disorders of Sex Development'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004967', 'term': 'Estrogens'}, {'id': 'D000728', 'term': 'Androgens'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1992-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-04', 'studyFirstSubmitDate': '2002-01-08', 'studyFirstSubmitQcDate': '2002-01-08', 'lastUpdatePostDateStruct': {'date': '2012-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive function in girls with Turner Syndrome', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Turner syndrome', 'estrogen', 'androgen', 'growth hormone'], 'conditions': ['Turner Syndrome']}, 'referencesModule': {'references': [{'pmid': '20733274', 'type': 'DERIVED', 'citation': 'Zeger MP, Shah K, Kowal K, Cutler GB Jr, Kushner H, Ross JL. Prospective study confirms oxandrolone-associated improvement in height in growth hormone-treated adolescent girls with Turner syndrome. Horm Res Paediatr. 2011;75(1):38-46. doi: 10.1159/000317529. Epub 2010 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are to learn whether treatment with an androgen type hormone will improve the visual-spatial problems associated with Turner syndrome, and to evaluate the effect growth hormone, with and without androgen, has on growth.', 'detailedDescription': 'Turner syndrome is associated with short stature, multiple physical stigmata, absent pubertal development, and increased learning problems. This study is designed to (1) examine the effects of sex steroids (androgen and estrogen) on multiple variables including growth rate, GH binding protein, IGF-I, IGFBP3, and cognitive function in the setting of supplemental growth hormone administration and (2) to investigate any synergistic or additive effects of the androgen and estrogen combination versus each alone, on the above variables.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Karyotype diagnosis compatible with Turner syndrome, but no presence of any Y material in the peripheral karyotype unless a gonadectomy has been performed;\n* Chronological age between 10.0 and 14.9 years;\n* Bone age less than or equal to 12 years; and\n* No treatment with estrogen, androgen, growth hormone, or any other growth-promoting agents exceeding 12 months, and no treatment with any of these agents in the previous 3 months.'}, 'identificationModule': {'nctId': 'NCT00029159', 'briefTitle': 'The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'The Effects of Androgen, Estrogen, and the Combination of Androgen and Estrogen on Growth Rate and Cognitive Function of Growth Hormone-treated Girls With Turner Syndrome', 'orgStudyIdInfo': {'id': 'R01NS032531', 'link': 'https://reporter.nih.gov/quickSearch/R01NS032531', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: estrogen', 'Drug: androgen']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: estrogen', 'Other: placebo']}], 'interventions': [{'name': 'estrogen', 'type': 'DRUG', 'description': 'Participants were started on ethinyl estradiol at a daily dose of 50ng/kg at the beginning of the 3rd year of the study. The estrogen was continued until study end.', 'armGroupLabels': ['1', '2']}, {'name': 'androgen', 'type': 'DRUG', 'description': 'Oxandrolone or placebo capsule, .06mg/kg/day, orally, for 2 years', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'an inactive substance', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital, 1025 Walnut Street, Suite 726', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Judith L. Ross, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}