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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02355860
Other study ID # 11D.84
Secondary ID
Status Completed
Phase N/A
First received November 18, 2014
Last updated January 30, 2015
Start date May 2010
Est. completion date October 2010

Study information

Verified date January 2015
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Description:

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.

Methods: 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.


Recruitment information / eligibility

Status Completed
Enrollment 268
Est. completion date October 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- women age 18 or older, presenting for an annual routine gynecology appointment, and were sexually active in the past six months

Exclusion Criteria:

- 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.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Behavioral:
assessment
assessment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Brett Worly, MD

Outcome

Type Measure Description Time frame Safety issue
Primary FSF Index Questionnaire Day 1 No
Secondary Health Information Assessment Questionnaire Day 1 No
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