Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT01065220
Status:
COMPLETED
Last Update Posted:
2014-01-03
First Post:
2010-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sex Steroids and the Serotonin Transporter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014189', 'term': 'Transsexualism'}, {'id': 'D000068116', 'term': 'Gender Dysphoria'}], 'ancestors': [{'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010792', 'term': 'testosterone undecanoate'}, {'id': 'D008234', 'term': 'Lynestrenol'}, {'id': 'D017373', 'term': 'Cyproterone Acetate'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D058891', 'term': '5-alpha Reductase Inhibitors'}], 'ancestors': [{'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003534', 'term': 'Cyproterone'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013258', 'term': 'Steroids, Chlorinated'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D045166', 'term': 'Estradiol 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': 'D065088', 'term': 'Steroid Synthesis Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-02', 'studyFirstSubmitDate': '2010-02-08', 'studyFirstSubmitQcDate': '2010-02-08', 'lastUpdatePostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography', 'timeFrame': '5 months', 'description': 'The serotonin-transporter BP will be assessed in a 90 min. dynamic PET measurement session at three timepoints: before start of hormonal therapy, after four weeks of hormonal therapy, and after 4 months of hormonal therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Serotonin Transporter', 'Hormone therapy', 'Gender Dysphoria', 'Transsexualism'], 'conditions': ['Transsexualism']}, 'referencesModule': {'references': [{'pmid': '25497691', 'type': 'DERIVED', 'citation': 'Kranz GS, Wadsak W, Kaufmann U, Savli M, Baldinger P, Gryglewski G, Haeusler D, Spies M, Mitterhauser M, Kasper S, Lanzenberger R. High-Dose Testosterone Treatment Increases Serotonin Transporter Binding in Transgender People. Biol Psychiatry. 2015 Oct 15;78(8):525-33. doi: 10.1016/j.biopsych.2014.09.010. Epub 2014 Sep 23.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to prove the influence of the sex steroid hormones estrogen, progesterone and testosterone on the serotonin transporter (5-HTT) binding using positron emission tomography (PET) and the selective radioligand \\[11C\\]DASB. Specifically, the 5-HTT binding will be quantified before and after hormone therapy underwent by 10 male-to-female (MtF) and 10 female-to-male (FtM) transsexuals urging for hormone treatment. The high-level, long-term administration of opsite sex steroid hormones in transsexuals provide the unique opportunity to investigate the influence of sex steroid hormones on the serotonergic system. Since the serotonin transporter serves as a primary target molecule for antidepressant treatment, the results of the study will be of benefit for the assessment of the clinical relevance of estrogen and testosterone as modulatory and neuroactive agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* somatic health\n* no previous sex hormone medication\n* willingness to sign the written informed consent\n\nExclusion Criteria:\n\n* severe diseases\n* steroid hormone treatment within 6 months prior inclusion\n* treatment with psychotropic agents such as selective serotonin reuptake inhibitors (SSRIs)\n* any implant or stainless steel graft\n* positive urine pregnancy test in women at the screening visit at each PET day'}, 'identificationModule': {'nctId': 'NCT01065220', 'briefTitle': 'Sex Steroids and the Serotonin Transporter', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'The Influence of Sex Steroid Hormones on Serotonin Transporter Binding in the Human Brain Investigated by Positron Emission Tomography', 'orgStudyIdInfo': {'id': 'AP13214ONB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hormone treatment for MtF', 'description': '* cyproterone acetate\n* estradiol\n* alpha-5-reductase-inhibitor', 'interventionNames': ['Drug: Cyproterone Acetate', 'Drug: Estradiol', 'Drug: 5-alpha reductase inhibitor']}, {'type': 'EXPERIMENTAL', 'label': 'hormone treatment for FtM', 'description': '* testosterone undecanoate\n* lynestrenol', 'interventionNames': ['Drug: Testolactone undecanoate', 'Drug: Lynestrenol']}], 'interventions': [{'name': 'Testolactone undecanoate', 'type': 'DRUG', 'otherNames': ['Nebido®'], 'description': '4ml i.m.', 'armGroupLabels': ['hormone treatment for FtM']}, {'name': 'Lynestrenol', 'type': 'DRUG', 'otherNames': ['Orgametril®'], 'description': '2/day', 'armGroupLabels': ['hormone treatment for FtM']}, {'name': 'Cyproterone Acetate', 'type': 'DRUG', 'otherNames': ['Androcur®'], 'description': '50mg per day', 'armGroupLabels': ['hormone treatment for MtF']}, {'name': 'Estradiol', 'type': 'DRUG', 'otherNames': ['Estradot®'], 'description': '100 microgram TTS twice a week', 'armGroupLabels': ['hormone treatment for MtF']}, {'name': '5-alpha reductase inhibitor', 'type': 'DRUG', 'otherNames': ['Finasterid®'], 'description': '1mg daily', 'armGroupLabels': ['hormone treatment for MtF']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Department of Psychiatry and Psychotherapy, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Rupert Lanzenberger, MD A/Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'A/Prof. PD Dr.', 'investigatorFullName': 'Rupert Lanzenberger', 'investigatorAffiliation': 'Medical University of Vienna'}}}}