Clinical trial NCT02862184: Female Sexual Dysfunction, Risks and Outcomes (FSFI)
Official title: Female Sexual Dysfunction, Risks and Outcomes (FSFI)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Female Sexual Dysfunction
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2016-08-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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. - See more at: http://www.uspharmacist.com/content/d/featured_articles/c/56908/#sthash.LTDkyRlR.dpuf

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

None

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Primary outcomes:
measure: Number of women with similar characteristics
timeFrame: 1 year
Secondary outcomes:
measure: Number of women with history of risk factors contribute to sexual dysfunction
timeFrame: 1 year
measure: Number of women with successful treatment of sexual dysfunction.
timeFrame: 1 year
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: St. Mary's Health Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Becky Lynn, MD
role: PRINCIPAL_INVESTIGATOR
References: