Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT02355860
Status:
COMPLETED
Last Update Posted:
2015-02-04
First Post:
2014-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Female Sexual Function and Socioeconomic Status
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-30', 'studyFirstSubmitDate': '2014-11-18', 'studyFirstSubmitQcDate': '2015-01-30', 'lastUpdatePostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FSF Index', 'timeFrame': 'Day 1', 'description': 'Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Health Information Assessment', 'timeFrame': 'Day 1', 'description': 'Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sexual Dysfunction']}, 'descriptionModule': {'briefSummary': 'In an urban gynecology practice serving patients with publicly and privately funded insurance, female sexual dysfunction was associated with low income, depression, urinary incontinence, and sexual inactivity.', 'detailedDescription': 'Introduction: Female sexual dysfunction is common, and the effect of socioeconomic status in an urban population is unknown. The objective is to determine socioeconomic and clinical factors associated with female sexual dysfunction for patients with publicly and privately funded health insurance in an urban outpatient gynecology clinic.\n\nMethods: We performed an observational, IRB approved, cross-sectional study of 238 sexually-active, non-pregnant women reporting to two urban gynecology clinics, representing patients with publicly funded (n=70) or privately funded health insurance (n=168). The participants completed validated questionnaires measuring sexual function (Female Sexual Function Index or FSFI), depression (Center for Epidemiologic Studies Depression Scale), urinary incontinence (Questionnaire for Urinary Incontinence Diagnosis), and demographic variables. Data was analyzed with non-parametric t-tests, chi-squared tests, and linear regression models.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '238 sexually-active, non-pregnant women reporting to two urban gynecology clinics, representing patients with publicly funded (n=70) or privately funded health insurance (n=168).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women age 18 or older, presenting for an annual routine gynecology appointment, and were sexually active in the past six months\n\nExclusion Criteria:\n\n* pregnant women, women who were less than six weeks post-partum, women reporting for a gynecologic problem visit, non-English speakers, incomplete survey questionnaires, or refusal to consent to participate in the study.'}, 'identificationModule': {'nctId': 'NCT02355860', 'briefTitle': 'Female Sexual Function and Socioeconomic Status', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Female Sexual Function and Socioeconomic Status', 'orgStudyIdInfo': {'id': '11D.84'}}, 'armsInterventionsModule': {'interventions': [{'name': 'assessment', 'type': 'BEHAVIORAL', 'description': 'assessment'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brett Worly, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Brett Worly, MD', 'investigatorAffiliation': 'Ohio State University'}}}}