An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women >= 15 Years of Age, in the Kingdom of Saudi Arabia

GlaxoSmithKline1 site in 1 country420 target enrollmentApril 2010

ConditionsInfections, Papillomavirus Cervical Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infections, Papillomavirus
Sponsor: GlaxoSmithKline
Enrollment: 420
Locations: 1
Primary Endpoint: Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (including multiple infections) among women undergoing cervical screening.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to determine the prevalence of human papillomavirus (HPV) and to assess the HPV type distribution among women >= 15 years of age, attending routine gynaecological examination in the Kingdom of Saudi Arabia.

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

December 2011

Last Updated

13 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects/Subjects' parents or guardians, who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study,
•Women \>=15 years of age attending a clinic for routine cervical screening,
•Written informed consent obtained from the subject and/or subject's parent/guardian.

Exclusion Criteria

•Referral for abnormal cervical sample at the current visit,
•Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed,
•No cervical sample provided,
•History of hysterectomy,
•Known diagnosis of immunosuppression, or patient on immunosuppressives,
•Pregnant female \>=25 years of age.

Outcomes

Primary Outcomes

Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (including multiple infections) among women undergoing cervical screening.

Time Frame: At least 12 months from the date of subject enrolment

Secondary Outcomes

Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (high risk and low risk) among women of different age strata undergoing cervical screening.(At least 12 months from the date of subject enrolment)
Level of awareness of human papillomavirus and its relation to transmission and to causation of cervical cancer.(At least 12 months from the date of subject enrolment)
Behavioural risk factors such as age at first marriage and age at first pregnancy (assessed through administration of a behavioural questionnaire).(At least 12 months from the date of subject enrolment)