Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-27 @ 4:15 AM
Study NCT ID:
NCT01062568
Status:
COMPLETED
Last Update Posted:
2019-08-26
First Post:
2010-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Adrenal Contribution to Androgen Production in Girls During Puberty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000324', 'term': 'Adrenocorticotropic Hormone'}, {'id': 'D003366', 'term': 'Cosyntropin'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rjchang@ucsd.edu', 'phone': '858-534-8930', 'title': 'Dr. R. Jeffery Chang', 'organization': 'UCSD'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Early Puberty', 'description': 'Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.\n\nAdrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.\n\n.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Late Puberty', 'description': 'Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.\n\nAdrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '17-hydroxyprogesterone Response to ACTH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Puberty Group', 'description': 'Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.'}, {'id': 'OG001', 'title': 'Late Puberty Group', 'description': 'Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.'}, {'id': 'OG002', 'title': 'Total Number', 'description': 'Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.\n\nAdrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.\n\nDex'}], 'classes': [{'title': 'Normal Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Over Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 and 60 minutes after ACTH administration', 'description': '17-hyrooxyprogesterone levels before and after ACTH', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is performed on a normal weight group comprised of 4 early puberty and 10 late puberty girls and an overweight group of 6 early puberty and 30 late puberty girls'}, {'type': 'SECONDARY', 'title': 'Free Testosterone Response to ACTH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Puberty Group', 'description': 'Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.\n\nAdrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this , adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood will be obtained for repeat hormone measurements.'}, {'id': 'OG001', 'title': 'Late Puberty Group', 'description': 'Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.\n\nAdrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this , adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood will be obtained for repeat hormone measurements.'}], 'classes': [{'title': 'Normal weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '7', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Overweight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '32', 'spread': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 and 60 min after ACTH administration', 'description': 'Free Testosteorne levels before and after ACTH', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is performed on a normal weight group comprised of 4 early puberty and 10 late puberty girls and an overweight group of 6 early puberty and 30 late puberty girls'}, {'type': 'SECONDARY', 'title': 'Androstenedione Response to ACTH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Early Puberty', 'description': 'Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.\n\nAdrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this , adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood will be obtained for repeat hormone measurements.'}, {'id': 'OG001', 'title': 'Late Puberty', 'description': 'Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this , adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.\n\nAdrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone . At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.'}], 'classes': [{'title': 'Normal Wieght', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Overweight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 and 60 min after ACTH administration', 'description': 'Androstenedione levels before and after ACTH', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is performed on a normal weight group comprised of 4 early puberty and 10 late puberty girls and an overweight group of 6 early puberty and 30 late puberty girls'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Early Puberty Group', 'description': 'Subjects were subdivided into normal weight and overweight groups. Blood was drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.\n\nAdrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take a oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood will be obtained for repeat hormone measurements.'}, {'id': 'FG001', 'title': 'Late Puberty Group', 'description': 'Subjects were subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.\n\nAdrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.\n\nDex'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Early Puberty Group', 'description': 'Subjects were subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.\n\nAdrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.\n\nDex'}, {'id': 'BG001', 'title': 'Late Puberty Group', 'description': 'Subjects were further subdivided into normal weight and overweight groups. Subjects will have blood drawn at 1900 hr for baseline measurements. At 2200 hr each subject will take dexamethasone. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered. At 30 and 60 minutes after ACTH, blood will be obtained for repeat hormone measurements.\n\nAdrenocorticotropin: Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood drawn for hormone measurements. After this, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.\n\nDex'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Normal Wieght', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.8', 'spread': '1', 'groupId': 'BG000'}, {'value': '13.9', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '12.1', 'spread': '1', 'groupId': 'BG002'}]}]}, {'title': 'Overweight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '14.9', 'spread': '0.4', 'groupId': 'BG001'}, {'value': '12.4', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-08', 'studyFirstSubmitDate': '2010-02-03', 'resultsFirstSubmitDate': '2019-06-10', 'studyFirstSubmitQcDate': '2010-02-03', 'lastUpdatePostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-08', 'studyFirstPostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '17-hydroxyprogesterone Response to ACTH', 'timeFrame': '0 and 60 minutes after ACTH administration', 'description': '17-hyrooxyprogesterone levels before and after ACTH'}], 'secondaryOutcomes': [{'measure': 'Free Testosterone Response to ACTH', 'timeFrame': '0 and 60 min after ACTH administration', 'description': 'Free Testosteorne levels before and after ACTH'}, {'measure': 'Androstenedione Response to ACTH', 'timeFrame': '0 and 60 min after ACTH administration', 'description': 'Androstenedione levels before and after ACTH'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adolescents', 'puberty', 'androgens', 'hyperandrogenemia'], 'conditions': ['Development']}, 'descriptionModule': {'briefSummary': "In girls with elevated androgens the precise source of androgen excess throughout puberty and early adolescence has not been carefully examined. The investigators propose to examine whether the adrenal gland produces the majority of androgens during puberty by studying the differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare steroid changes before and 60 min after ACTH administration in NW and OB girls.", 'detailedDescription': 'Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin hormone (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal CBC (Hemoglobin must be at least 11mg/dl)\n* Normal renal and liver function tests (AST\\& ALT 10-45 IU/L; Albumin 3.3-5 g/dL; Alk phos 30-130 IU/L;\n* direct bili \\<0.2 mg/dL;\n* total bili \\<1.2 mg/dL; total protein 6.0-8.0 g/dL) Normal vital signs including normal blood pressure (pulse 60-100/min, respirations 12-20/min, BP 80/60-130/80)\n\nExclusion Criteria:\n\n* Pregnancy\n* On oral contraceptives\n* On insulin lowering drugs\n* On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)\n* On medications that will influence androgen metabolism or clearance\n* On medications that will inhibit the cytochrome P450 enzyme system (cimetidine, ketoconazole, etc)\n* Subjects with morning cortisol\\<5 ug/dL will be excluded and asked to see their primary care physician.\n* Subjects with 17-OHP\\>250 ng/dL) will be excluded and asked to see their primary care physician.\n* Subject with a history of Cushing syndrome or adrenal insufficiency will be excluded'}, 'identificationModule': {'nctId': 'NCT01062568', 'briefTitle': 'The Adrenal Contribution to Androgen Production in Girls During Puberty', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'The Adrenal Contribution to Androgen Production in Girls During Puberty', 'orgStudyIdInfo': {'id': '091676'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obese group', 'description': 'Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.', 'interventionNames': ['Drug: Adrenocorticotropin', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Nonobese group', 'description': 'Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.', 'interventionNames': ['Drug: Adrenocorticotropin', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Adrenocorticotropin', 'type': 'DRUG', 'otherNames': ['Cosyntropin', 'ACTH'], 'description': 'Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.', 'armGroupLabels': ['Nonobese group', 'Obese group']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['dex'], 'description': 'Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.', 'armGroupLabels': ['Nonobese group', 'Obese group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of california, san diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'R J Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jeffrey Chang, MD', 'investigatorAffiliation': 'University of California, San Diego'}}}}