Evaluation of Prevalence of Sexuality Alteration in Women With an Abnormal Pap Test (EVASEF)

September 12, 2023 updated by: Centre Hospitalier Universitaire, Amiens

Human Papilloma virus is the most common sexual infection in women, which can leads to cervical lesion and cervical cancer. Pap test is recommanded in women of 25 years old until 65 years old in order to screen subclinic lesions and improve prognosis. Yet, scientific knowledge about chronic disease showed negative consequences on quality of life.

However, no study until now has striven to evaluate the consequences of an abnormal pap test on sexuality in adult women. The aim of this study is to evaluate if an abnormal pap test have an impact on the sexual functions in women because of the anxiety and psychological consequences of the diagnosis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80480
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult women with an abnormal pap test.
  • Diagnosis known 4 to 12 weeks before the appointment for colposcopy

Exclusion Criteria:

  • Cervical cancer
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adult women with an abnormal pap test
Other: questionnary
If agreeing to the protocol, ; patients will answered questions about sexual health during the gynecologic consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% ofpositive response rate at the first question of the questionnaire
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of causes of woman alteration sexual function alteration
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2022

Primary Completion (Actual)

September 12, 2023

Study Completion (Actual)

September 12, 2023

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PI2019_843_0105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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