NCT02355860

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
Last Updated

February 4, 2015

Status Verified

January 1, 2015

Enrollment Period

4 months

First QC Date

November 18, 2014

Last Update Submit

January 30, 2015

Conditions

Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

  • FSF Index

    Questionnaire

    Day 1

Secondary Outcomes (1)

  • Health Information Assessment

    Day 1

Interventions

assessmentBEHAVIORAL

assessment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

November 18, 2014

First Posted

February 4, 2015

Study Start

May 1, 2010

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

February 4, 2015

Record last verified: 2015-01