An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus (HPV) Types in Women >= 18 Years of Age, in Egypt

GlaxoSmithKline1 site in 1 country490 target enrollmentOctober 2010

ConditionsHuman Papillomavirus Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Human Papillomavirus Infection
Sponsor: GlaxoSmithKline
Enrollment: 490
Locations: 1
Primary Endpoint: Occurrence of Human papillomavirus (HPV) DNA and of any of the HPV types among women undergoing cervical sample testing.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to determine the Human Papillomavirus (HPV) prevalence and HPV type distribution among women aged >= 18 years, attending out-patient health services for gynaecological examination and who agree to HPV testing in Egypt .

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

August 2011

Last Updated

13 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women \>= 18 years of age attending a clinic for gynaecological examination.
•Women who agree to provide a cervical sample for human papillomavirus testing.
•Written informed consent obtained from the subject.

Exclusion Criteria

•Referral for abnormal cervical sample at the current visit.
•Abundant menstrual bleeding or vaginal discharge not allowing appropriate screening to be performed.
•History of hysterectomy.
•Known diagnosis of immunosuppression, or patient on immunosuppressives.
•Pregnant women.
•Having received one or more doses of HPV vaccine prior to participating in the study.

Outcomes

Primary Outcomes

Occurrence of Human papillomavirus (HPV) DNA and of any of the HPV types among women undergoing cervical sample testing.

Time Frame: Average timeframe: 12 months

Secondary Outcomes

Occurrence of HPV DNA and of any of the HPV types among women of different age-strata undergoing cervical sample testing(Average timeframe: 12 months)
Behavioural risk factors assessed by behavioral questionnaire(At the single study visit (Day 0))
Assessing the awareness of HPV in relation to transmission and cause of cervical cancer(At the single study visit (Day 0))