Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT03558451
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2018-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicentre Clinical Trial. Project EXIMe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074384', 'term': 'Sexual Health'}], 'ancestors': [{'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only primary care midwives know and apply the intervention'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2018-02-05', 'studyFirstSubmitQcDate': '2018-06-14', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main-Quality of life in menopause', 'timeFrame': 'Change from baseline Quality of life at six months', 'description': 'Main-Quality of life in menopause measured with "Cervantes Short-Form Scale" (20 -100 points)'}], 'secondaryOutcomes': [{'measure': 'Sexual function', 'timeFrame': 'Change from baseline at six months', 'description': 'Sexual function: measured with Questionnaire "Health and female sexual dysfunction in primary care"'}, {'measure': 'vaginal pH', 'timeFrame': 'Change from baseline at six months', 'description': 'vaginal pH'}, {'measure': 'Oxford scale', 'timeFrame': 'Change from baseline at six months', 'description': 'Oxford scale: pelvic floor muscle response'}, {'measure': 'Urine sediment', 'timeFrame': 'Change from baseline at six months', 'description': 'Urine sediment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary health care'], 'conditions': ['Menopause']}, 'descriptionModule': {'briefSummary': 'Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid.', 'detailedDescription': 'Genitourinary Syndrome of Menopause is a common condition that increases by four the risk of having a sexual dysfunction, and that affects the quality of life of women who suffer it. Those women with an active sexual life have fewer symptoms associated with this syndrome. Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid. Population: women aged between 45-65 years with Genitourinary Syndrome of Menopause attending to the midwife consultation. N= 250 (125 women in each group) will be included by midwifes in the Primary Health Care consultations in the Community of Madrid. Control group: women will receive the usual assistance.\n\nExperimental group: in addition to the usual assistance, women will receive a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used. Variables: Main-Quality of life in menopause (measured with the Cervantes Short-Form Scale). Secondary- sociodemographic variables, sexual history and variables related to the Genitourinary Syndrome of Menopause. Analysis: by intention-to-treat, comparing the quality of life in menopause scores before/after the intervention in both groups after 0, 1 and 6 months. To explain the factors associated with a higher quality of life, a linear regression model would be fitted.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women aged between 45-65 years with Genitourinary Syndrome of Menopause\n\nExclusion Criteria:\n\n* women who present pathologies that lead to an alteration of sexual desire\n* women who receive or have received in the last six months treatment that increase the incidence of vaginal atrophy\n* women who receive or have received local hormonal therapy during the last month, systemic hormonal therapy in the last six months, or other systemic treatment for the Genitourinary Syndrome of Menopause\n* women who could not read or write, and not understand the spanish language.'}, 'identificationModule': {'nctId': 'NCT03558451', 'acronym': 'EXIMe', 'briefTitle': 'Multicentre Clinical Trial. Project EXIMe', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Gerencia de Atención Primaria, Madrid'}, 'officialTitle': 'Effectiveness of a Sexual Health Intervention in Women With Genitourinary Syndrome of Menopause to Improve Their Quality of Life. Multicentre Clinical Trial. Project EXIMe', 'orgStudyIdInfo': {'id': 'CCI 24/16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EXIMe intervention', 'description': 'In addition to the usual assistance, women will receive a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used.', 'interventionNames': ['Other: Complex intervention in sexual health', 'Other: Usual care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Usual care according to available protocols applicable to the women and the health service standardized portfolio', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'Complex intervention in sexual health', 'type': 'OTHER', 'otherNames': ['Usual care'], 'description': 'EXIMe is a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used.', 'armGroupLabels': ['EXIMe intervention']}, {'name': 'Usual care', 'type': 'OTHER', 'otherNames': ['Women will receive the usual assistance'], 'description': 'According to available protocols applicable to the patient and the health service standardized portfolio', 'armGroupLabels': ['EXIMe intervention', 'Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28035', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Gerencia de Atención Primaria, Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Lucia Martinez-Villarejo, Midwife', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gerencia de Atención Primaria, Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gerencia de Atención Primaria, Madrid', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Fundación de Innovación e Investigación Biomédica de Atención Primaria-Madrid', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}