NCT01252576

Brief Summary

300 italian women will be enroll for linguistic and cultural validation in italian of Female sexual function index (FSFI). This questionnaire is used in most countries to investigate female sexual function. To date there are not validate questionnaires in italian on female sexual function. We decided to start the validation process to give a validated tool to italian investigators.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2011

Enrollment Period

6 months

First QC Date

December 1, 2010

Last Update Submit

June 21, 2011

Conditions

Sexual Dysfunction

Keywords

FSFIfemale sexual functionitalian validation

Outcome Measures

Primary Outcomes (1)

  • Test-retest reliability of FSFI italian translation

    Test-retest reliability of professional translation in italian language of female sexual function index test.

    15 days

Study Arms (1)

women with and without sexual dysfunction

women with and without female sexual dysfunction

Eligibility Criteria

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

women from general population whit or without sexual dysfunction

You may qualify if:

  • women aged 18-65 years

You may not qualify if:

  • mental diseases that do not permit to understand questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SS Annunziata Hospital

Savigliano, Cuneo, 12030, Italy

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Maria Teresa Filocamo, MD

    Club Italiano Femminile di Urologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2010

First Posted

December 3, 2010

Study Start

December 1, 2010

Primary Completion

June 1, 2011

Last Updated

June 22, 2011

Record last verified: 2011-06

Locations

IT(1)