Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-02 @ 9:23 AM
Study NCT ID:
NCT07131267
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Sexual Functioning in Trans Men During the Gender Affirmation Process: A Mixed Methods Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sexual functioning', 'timeFrame': 'Day 1', 'description': 'Arizona Sexual Experience Scale: It is designed to measure five specific items identified as fundamental elements of sexual function. The scale was designed by McGahuey (McGahuey et al., 1997). The Turkish validity and reliability of the scale was conducted by Atilla Soykan (Soykan, 2004). Higher scores indicate higher levels of dysfunction.'}, {'measure': 'Sexual desire', 'timeFrame': 'Day 1', 'description': "Sexual Desire Inventory-2: It is a 14-item, self-administered questionnaire measuring sexual desire (Spector et al., 1996). It includes subscales of sexual motivation, sexual satisfaction, sexual relationship quality, activity frequency, and behavioral diversity to capture the multidimensional nature of sexual desire. The Turkish validity and reliability of the scale, along with other languages, were conducted in Castro-Calvo's study (Castro-Calvo et al., 2024). High scores indicate high sexual desire."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sexual functioning', 'transgender men', 'gender affirmation'], 'conditions': ['Sexual Functioning', 'Transgender Men', 'Gender Affirmation Surgery']}, 'descriptionModule': {'briefSummary': 'Both sexual experiences and the process of gender transition initiated to reduce gender dysphoria carry cultural characteristics. Gender categories, societal expectations for each gender, and attitudes toward sexual minorities in a given society can shape the lived experiences of trans individuals. Therefore, research on individuals with gender dysphoria in different cultural contexts is of great importance. To our knowledge, no study in Türkiye has examined sexual functioning in trans individuals undergoing gender transition. For this reason, our study aimed to investigate how sexual functioning is affected by the gender transition process in trans men with gender dysphoria, using both quantitative and qualitative methods.', 'detailedDescription': 'For the quantitative part of the study, 52 participants will receive a sociodemographic and clinical data form, Arizona Sexual Experiences Scale, Sexual Desire Inventory, Utrecht Gender Dysphoria Scale, Depression Anxiety Stress Scale-21, and WHOQOL-100 sexual quality of life subscale.\n\nWhile performing a qualitative study, 12 participants will receive questions about their sexual functioning during the gender affirmation process.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Trans men during the gender affirmation process', 'genderDescription': 'Trans men during the gender affirmation process', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n18 years or older Diagnosed with gender dysphoria by two different physicians Getting medical support for the gender affirmation process\n\nExclusion Criteria:\n\nOver 65 years Diagnosed with intellectual disability, dementia, or organic mental disorders Having a systemic disease that negatively impacts sexual function Getting a score above 3 on the Clinical Global Impression Scale'}, 'identificationModule': {'nctId': 'NCT07131267', 'acronym': 'ESFTMGAP', 'briefTitle': 'Evaluating Sexual Functioning in Trans Men During the Gender Affirmation Process: A Mixed Methods Study', 'organization': {'class': 'OTHER', 'fullName': 'Eskisehir Osmangazi University'}, 'officialTitle': 'Evaluating Sexual Functioning in Trans Men During the Gender Affirmation Process: A Mixed Methods Study', 'orgStudyIdInfo': {'id': 'EskisehirOU 28.05.2025/26'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Trans men during the gender affirmation process'}]}, 'contactsLocationsModule': {'locations': [{'zip': '26040', 'city': 'Eskişehir', 'state': 'Türkiye', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Imran G Yilmaz-Karaman, Assoc.Prof.', 'role': 'CONTACT', 'email': 'imrangokcen.yilmazkaraman@ogu.edu.tr', 'phone': '00902222392979', 'phoneExt': '3604'}, {'name': 'Aylin Aydin, Assisst.Dr.', 'role': 'CONTACT', 'email': 'dr.aylinaydin@gmail.com', 'phone': '00902222392979', 'phoneExt': '3600'}], 'facility': 'Eskişehir Osmangazi University, Faculty of Medicine, Department of Psychiatry', 'geoPoint': {'lat': 39.77667, 'lon': 30.52056}}], 'centralContacts': [{'name': 'Imran G Yilmaz-Karaman, Assoc.Prof.', 'role': 'CONTACT', 'email': 'imrangokcen.yilmazkaraman@ogu.edu.tr', 'phone': '02222392979', 'phoneExt': '3600'}, {'name': 'Aylin Aydin, Assist.Dr.', 'role': 'CONTACT', 'email': 'gokcenylmz@yahoo.com', 'phone': '02222392979', 'phoneExt': '3600'}], 'overallOfficials': [{'name': 'Imran G Yilmaz-Karaman, Assoc.Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eskişehir Osmangazi University, Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eskisehir Osmangazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor doctor', 'investigatorFullName': 'Imran Gokcen Yilmaz-Karaman', 'investigatorAffiliation': 'Eskisehir Osmangazi University'}}}}