Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-30 @ 2:10 AM
Study NCT ID:
NCT06253403
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-13
First Post:
2024-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sexual Dysfunction and Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011613', 'term': 'Psychotherapy'}], 'ancestors': [{'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-10', 'studyFirstSubmitDate': '2024-02-02', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Female Sexual function index (FSFI)', 'timeFrame': '1 day', 'description': "A self-administered questionnaire was utilized to gather information on participants' sexual experiences and satisfaction over the past four weeks. The questionnaire encompasses six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain, each rated on a scale of 0 to 5. A lower score indicates a higher likelihood of sexual dysfunction.The maximum attainable score is 36 and minimum is 2, with a cut off of 26 serving as a potential diagnostic threshold for sexual dysfunction"}], 'secondaryOutcomes': [{'measure': 'The Eating Disorder Examination - Questionnaire Short (EDE-QS', 'timeFrame': '1 day', 'description': 'The Eating Disorder Examination - Questionnaire Short (EDE-QS) is a concise 12-item version featuring a 4-point response scale. The maximum attainable score is 36 and minimum is 0, with a cut off of 15 serving as a potential diagnostic threshold for eating disorder. Higher score indicate worse outcome.This instrument is designed to assess eating disorder (ED) symptoms observed within the preceding 7 days. The screening EDE-QS aims to efficiently identify probable ED symptomatology while demonstrating robust psychometric properties.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sexual dysfunction, anorexia nervosa, women, libido'], 'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'The objective of this observational study is to investigate the potential influence of anorexia nervosa on the sexual health of women. The primary focus is to determine the presence of sexual dysfunction in individuals with anorexia nervosa and explore any potential correlation between eating disorders and sexual dysfunction. To facilitate comparison, data from a control group comprising healthy women is incorporated alongside the clinical group data.', 'detailedDescription': 'numerous studies indicate that women diagnosed with anorexia nervosa experience a discernible impact on their sexual well-being, often accompanied by symptoms of sexual dysfunction (SD). Such dysfunction may manifest as a diminished libido, reduced sexual desire, and challenges in achieving orgasm'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects within the clinical group are women diagnosed with either AN or a history of anorexia nervosa', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nclinic group :\n\n* adult\n* women\n* diagnosis of anorexia nervosa\n* from Slovakia and Czech Republic\n\ncontrol group:\n\n* health women\n* adult\n* from Slovakia and Czech Republic\n\nExclusion Criteria:\n\nclinic group:\n\n* health women\n* other diagnosis or disorder\n* other country\n\ncontrol group:\n\n* presence of some mental illness\n* other country'}, 'identificationModule': {'nctId': 'NCT06253403', 'acronym': 'SD&MA', 'briefTitle': 'Sexual Dysfunction and Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Comenius University'}, 'officialTitle': 'Exploring Sexual Dysfunction in Women Affected by Anorexia Nervosa: Initial Insights', 'orgStudyIdInfo': {'id': 'study1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'clinic', 'description': 'adult women with anorexia nervosa or actual or after stabilization', 'interventionNames': ['Behavioral: psychotherapy']}, {'label': 'control', 'description': 'health adult women without any psychological or mental illnes'}], 'interventions': [{'name': 'psychotherapy', 'type': 'BEHAVIORAL', 'description': 'psychotherapy related to sexual intervention', 'armGroupLabels': ['clinic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Tatiana Hess', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Comenius University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral student, Clinical research', 'investigatorFullName': 'Tatiana Hess', 'investigatorAffiliation': 'Comenius University'}}}}