Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-30 @ 11:53 PM
Study NCT ID:
NCT03541395
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2018-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005058', 'term': 'Eunuchism'}], 'ancestors': [{'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C092464', 'term': 'LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-17', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Protein biomarkers', 'timeFrame': '48 months', 'description': 'Finding new protein biomarkers related to testosterone response'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypogonadism, Male']}, 'descriptionModule': {'briefSummary': 'The study is designed to identify and validate new protein biomarkers in blood related to testosterone activity. Thirty healthy young males underwent pharmaceutical castration to lower testosterone levels. After three weeks the subjects received an intramuscular injection of testosterone undecanoate. Blood samples from just before pharmaceutical castration, three weeks after castration, and one week after injection of testosterone undecanoate were collected representing normal testosterone levels, low testosterone levels, and testosterone at eugonadal levels.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nhealthy males\n\nExclusion Criteria:\n\nuse of anabolic steroids, use of narcotics,'}, 'identificationModule': {'nctId': 'NCT03541395', 'briefTitle': 'Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males Before and After Pharmacological Castration', 'orgStudyIdInfo': {'id': 'TP 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Testosterone', 'description': 'A Gonadotropin releasing hormone agonist (GnRH-agonist) is administered to lower the testosterone to castration levels. After four weeks testosterone undecanoate is administered to increase the testosterone to normal levels.', 'interventionNames': ['Drug: GnRH antagonist']}], 'interventions': [{'name': 'GnRH antagonist', 'type': 'DRUG', 'armGroupLabels': ['Testosterone']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Johan Malm, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lund University'}, {'name': 'Roger Appelqvist, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}, {'name': 'Gyorgy Marko-Varga, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}, {'name': 'Aleksander Giwercman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}, {'name': 'Barbara Sahlin, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Johan Malm', 'investigatorAffiliation': 'Lund University'}}}}