Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT06142851
Status:
UNKNOWN
Last Update Posted:
2023-11-22
First Post:
2023-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Women With Superficial Dyspareunia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2023-11-15', 'studyFirstSubmitQcDate': '2023-11-15', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'medical history', 'timeFrame': 'Day 0', 'description': 'Question to the woman about possible pain during sexual intercourses by an health professional (yes or no)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['superficial dyspareunia', 'management'], 'conditions': ['Superficial Dyspareunia']}, 'descriptionModule': {'briefSummary': 'Superficial dyspareunia are persistent or recurrent pains during an attempt at sexual intercourse or during effective penetration.\n\nThey affect between 3 to 18% of women and are a source of physical and psychological suffering.\n\nSome health professionals (gynecologists, general practitioners, midwives) are confronted daily with these complaints.\n\nThe approach of sexuality remains a complex subject even within the medical field. As a result, communication between women and health professionals can be difficult, leading to delayed diagnosis or inadequate management.', 'detailedDescription': 'The main objective is to describe the management of superficial dyspareunia by health professionals.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with superficial dyspareunia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 or over\n* Superficial dyspareunia, i.e.:\n\n * Having already had several painful vaginal penetrative sex\n * Having pain at the intromission (at the beginning of the vagina and at the level of the vulva) and/or at the beginning of penetration (by a penis, fingers, sextoys)\n * Having persistent and/or recurrent pain (appearing in a manner regular)\n* Agreeing to participate in the study\n\nExclusion Criteria:\n\n* Minors\n* Protected by law (guardianship, curatorship, safeguarding of justice)\n* Refusing to participate in the study'}, 'identificationModule': {'nctId': 'NCT06142851', 'acronym': 'dyspareunie', 'briefTitle': 'Management of Women With Superficial Dyspareunia', 'organization': {'class': 'OTHER', 'fullName': 'Université de Reims Champagne-Ardenne'}, 'officialTitle': 'Management of Women With Superficial Dyspareunia', 'orgStudyIdInfo': {'id': '2023_RIPH_017_PEC-dyspareunie'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with superficial dyspareunia', 'description': 'Adult women, having sexual activity with or without vaginal penetration, suffering from superficial dyspareunia, whether or not managed by health professionals.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'data collection', 'armGroupLabels': ['Women with superficial dyspareunia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'Ufr Medecine Urca', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '51100', 'city': 'Reims', 'country': 'France', 'facility': 'Université de Reims Champagne Ardenne', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}], 'centralContacts': [{'name': 'Barbe Coralie, DR', 'role': 'CONTACT', 'email': 'coralie.barbe@univ-reims.fr', 'phone': '0326913665', 'phoneExt': '+33'}, {'name': 'CURRS CURRS', 'role': 'CONTACT', 'email': 'currs@univ-reims.fr', 'phone': '0326918822', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Reims Champagne-Ardenne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}