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

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05701020
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 17.6
• Patients Per Site Per Month: 22.7

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunction; Epidemiology	Other: questionnary	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Evaluation of Prevalence of Sexuality Alteration in Women With an Abnormal Pap Test
• Actual Study Start Date: Dec 13, 2022
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. % ofpositive response rate at the first question of the questionnaire [18 months]

Secondary Outcome Measures

1. Number of causes of woman alteration sexual function alteration [18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT05701020
• Other Study ID Numbers: PI2019_843_0105
• First Posted: Jan 27, 2023
• Last Update Posted: Jan 27, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire, Amiens: Abnormal pap test; Sexual Dysfunction; Epidemiology

Study Results

No Results Posted as of Jan 27, 2023