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Female Sexual Dysfunction, Risks and Outcomes (FSFI)

Sponsor
St. Louis University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02862184
Collaborator
(none)
0
Enrollment
1
Location
6
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Many women will likely experience a sexual problem in their lifetimes. The Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking (PRESIDE) study surveyed more than 30,000 U.S. women aged >18 years regarding sexual function. Results from this study estimated that 12% of women experience a diagnosable sexual disorder that causes personal distress, with lack of sexual desire being the most prevalent.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Standard of care includes completion of a sexual dysfunctional questionnaire at every visit. This study will collect information from the questionnaires and office visit and follow the patient for outcomes of successful or non successful treatment.

    The purpose of this study is to collect and analyze data on the characteristics of women who present with sexual dysfunction, to evaluate what risk factors contribute to sexual dysfunction and to evaluate what factors contribute to successful treatment of sexual dysfunction.

    Upon a visit to the office participants will complete the Female Sexual Function Index (FSFI), this is standard of care for all patients. Research related procedures include: Review of questionnaires and collecting data from medical records regarding medical history, and treatment outcomes. If a participant does not return to the office for a follow up visit (or final visit) the final questionnaire will be sent by their preference (e-mail, phone, or mail) noted in the consent form.

    Participates will also be given the option of participating in a "future storage of data". Future testing will be in the area of female sexual dysfunction. Data will be identified by a code number and only the research staff at Saint Louis University will have access to the data.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Female Sexual Dysfunction, Risks and Outcomes (FSFI)
    Study Start Date :
    Jul 1, 2016
    Actual Primary Completion Date :
    Jan 1, 2017
    Actual Study Completion Date :
    Jan 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Number of women with similar characteristics [1 year]

      Categorical variables will be expressed as frequencies and percentages. Continuous variables will be expressed as means and standard deviations and/or medians and ranges. Parametric and nonparametric statistical analysis will be conducted based on normality of distributions.

    Secondary Outcome Measures

    1. Number of women with history of risk factors contribute to sexual dysfunction [1 year]

      Categorical variables will be expressed as frequencies and percentages. Continuous variables will be expressed as means and standard deviations and/or medians and ranges. Parametric and nonparametric statistical analysis will be conducted based on normality of distributions.

    2. Number of women with successful treatment of sexual dysfunction. [1 year]

      Categorical variables will be expressed as frequencies and percentages. Continuous variables will be expressed as means and standard deviations and/or medians and ranges. Parametric and nonparametric statistical analysis will be conducted based on normality of distributions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 89 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Female 18 to 89 years of age Being treated at the Saint Louis University Clinic for Sexual Dysfunction

    Exclusion Criteria:

    None

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Mary's Health Center St. Louis Missouri United States 63117

    Sponsors and Collaborators

    • St. Louis University

    Investigators

    • Principal Investigator: Becky Lynn, MD, St. Louis University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Becky Lynn, MD, Assistant Professor, St. Louis University
    ClinicalTrials.gov Identifier:
    NCT02862184
    Other Study ID Numbers:
    • 26311
    First Posted:
    Aug 10, 2016
    Last Update Posted:
    Jan 13, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Jan 13, 2017