Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05701020
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2023-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Prevalence of Sexuality Alteration in Women With an Abnormal Pap Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-12', 'studyFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '% ofpositive response rate at the first question of the questionnaire', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Number of causes of woman alteration sexual function alteration', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abnormal pap test', 'Sexual Dysfunction', 'Epidemiology'], 'conditions': ['Sexual Dysfunction', 'Epidemiology']}, 'descriptionModule': {'briefSummary': 'Human Papilloma virus is the most common sexual infection in women, which can leads to cervical lesion and cervical cancer. Pap test is recommanded in women of 25 years old until 65 years old in order to screen subclinic lesions and improve prognosis. Yet, scientific knowledge about chronic disease showed negative consequences on quality of life.\n\nHowever, no study until now has striven to evaluate the consequences of an abnormal pap test on sexuality in adult women. The aim of this study is to evaluate if an abnormal pap test have an impact on the sexual functions in women because of the anxiety and psychological consequences of the diagnosis'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Adult women with an abnormal pap test', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women with an abnormal pap test.\n* Diagnosis known 4 to 12 weeks before the appointment for colposcopy\n\nExclusion Criteria:\n\n* Cervical cancer\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT05701020', 'acronym': 'EVASEF', 'briefTitle': 'Evaluation of Prevalence of Sexuality Alteration in Women With an Abnormal Pap Test', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Evaluation of Prevalence of Sexuality Alteration in Women With an Abnormal Pap Test', 'orgStudyIdInfo': {'id': 'PI2019_843_0105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adult women with an abnormal pap test', 'interventionNames': ['Other: questionnary']}], 'interventions': [{'name': 'questionnary', 'type': 'OTHER', 'description': 'If agreeing to the protocol, ; patients will answered questions about sexual health during the gynecologic consultation', 'armGroupLabels': ['Adult women with an abnormal pap test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}