An Observational, Epidemiological Study on the Prevalence of Human Papillomavirus Types in Women in Egypt

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Human Papillomavirus Infection

Treatments: Procedure: Endocervical samples

Study type: Observational

Funder types: Industry

Identifiers

NCT01158209

113367

Details and patient eligibility

About

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 .

Enrollment: 490 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

490 participants in 1 patient group

Assessed cohort

Description:

Subjects attending out-patient health services for gynaecological examination.

Treatment:

Procedure: Endocervical samples