Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
Study NCT ID:
NCT05474768
Status:
UNKNOWN
Last Update Posted:
2022-07-26
First Post:
2022-07-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expectations and Beliefs of Transgender People Regarding Hormonal Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014189', 'term': 'Transsexualism'}], 'ancestors': [{'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-23', 'studyFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2022-07-23', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Describe expectations and beliefs of transgener people about hormonal therapy', 'timeFrame': '12 months', 'description': 'qualitative analysis of qualitative data from collective discussions (focus groups)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transgenderism']}, 'descriptionModule': {'briefSummary': 'Hormonal treatment of gender dysphoria can have repercussions on metabolism, cardiovascular system and fertility and represents à potential oncological risk. According to the recommendations of the Endocrine society. Therefore, initial assessment and follow-up visits are necessary and must be carried out to avoid the apparition of potentially undesirable effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adults with gender dysphoria and parent of adolescent/child presenting gender dysphoria, who are followed un the university hospital of Nancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being a parent of adolescent/child presenting Gender dysphoria\n* adult subject (age \\> 18 years) presenting Gender dysphoria\n\nnon-inclusion criteria\n\n* Severe, uncontrolled psychiatric or somatic illness\n* Chronic alcoholism\n* Substance abuse\n* Refusal or linguistic, physical or psychological incapacity to participate in the study\n* Ongoing pregnancy'}, 'identificationModule': {'nctId': 'NCT05474768', 'briefTitle': 'Expectations and Beliefs of Transgender People Regarding Hormonal Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Expectations and Beliefs of Transgender People Regarding Hormonal Treatment', 'orgStudyIdInfo': {'id': '2021PI221'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eva Feigerlova', 'role': 'CONTACT', 'email': 'e.feigerlova@chru-nancy.Fr', 'phone': '33 (0)3 83 15 34 12'}], 'facility': 'CHRU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'EVA FEIGERLOVA', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}