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NCT05701020 Clinical Trial

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

Sexual Dysfunction Clinical Trial

— EVASEF  

Official title:
Evaluation of Prevalence of Sexuality Alteration in Women With an Abnormal Pap Test

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05701020
Other study ID # PI2019_843_0105
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 13, 2022
Est. completion date September 12, 2023

Study information
Verified date September 2023
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date September 12, 2023
Est. primary completion date September 12, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• questionnary
If agreeing to the protocol, ; patients will answered questions about sexual health during the gynecologic consultation

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary % ofpositive response rate at the first question of the questionnaire 18 months
Secondary Number of causes of woman alteration sexual function alteration 18 months
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