NCT05701020

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

December 13, 2022

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

January 10, 2023

Last Update Submit

September 12, 2023

Conditions

Sexual DysfunctionEpidemiology

Keywords

Abnormal pap testSexual DysfunctionEpidemiology

Outcome Measures

Primary Outcomes (1)

  • % ofpositive response rate at the first question of the questionnaire

    18 months

Secondary Outcomes (1)

  • Number of causes of woman alteration sexual function alteration

    18 months

Study Arms (1)

Adult women with an abnormal pap test

EXPERIMENTAL
Other: questionnary

Interventions

questionnaryOTHER

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

Adult women with an abnormal pap test

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult women with an abnormal pap test
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Cervical cancer
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 27, 2023

Study Start

December 13, 2022

Primary Completion

September 12, 2023

Study Completion

September 12, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)