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Study on the Prevalence of Human Papillomavirus Types in Women >= 15 Years of Age in the Kingdom of Saudi Arabia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01213459
Enrollment
420
Registered
2010-10-04
Start date
2010-04-30
Completion date
2011-12-31
Last updated
2012-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Infections, Papillomavirus

Keywords

Human papillomavirus

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.

Interventions

PROCEDURECervical samples

Human papillomavirus detection and typing in cervical samples.

OTHERData collection

Questionnaire completion

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Prevalence of any human papillomavirus deoxyribo nucleic acid and of different types of human papillomavirus (including multiple infections) among women undergoing cervical screening.At least 12 months from the date of subject enrolment

Secondary

MeasureTime frame
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
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
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

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026