Sexual DysfunctionNCT02355860
Female Sexual Function and Socioeconomic Status
An observational study of Sexual Dysfunction, run by Brett Worly, MD.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 268 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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).
Who may be able to join
- women age 18 or older, presenting for an annual routine gynecology appointment, and were sexually active in the past six months
Who cannot join
- 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.
About this study
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.
Read the detailed 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.
- Conditions
- Sexual Dysfunction
- Being tested
- assessment
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentBehavioural
assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
FSF Index
Questionnaire
Measured: Day 1
Secondary outcomes (1)
Health Information Assessment
Questionnaire
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startMay 2010
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brett Worly, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brett Worly, MD, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355860
- Sponsor's protocol ID
- 11D.84
- Status last verified
- Jan 2015
- First submitted
- 18 Nov 2014
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Female Sexual Function and Socioeconomic Status
- ClinicalTrials.gov ID
- NCT02355860
- Acronym / sponsor ID
- 11D.84
- Conditions
- Sexual Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Brett Worly, MDUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (1 listed)
- women age 18 or older, presenting for an annual routine gynecology appointment, and were sexually active in the past six months
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessmentassessment | Behavioural | – |
Primary outcome
FSF Index
Time frame: Day 1
Questionnaire
1 secondary outcome
Health Information Assessment
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexual Dysfunction, run by Brett Worly, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FSF Index (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.