Status:
COMPLETED
Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This study is designed to provide up to four years of annual oncogenic HPV DNA testing and cervical cytology examination for NCT00122681 study subjects who displayed normal cervical cytology but teste...
Eligibility Criteria
Inclusion
- Written informed consent obtained from the subject prior to enrolment.
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A subject previously enrolled in the study NCT00122681 and who fulfils either of the following criteria:
- displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48).
- or
- \- was pregnant at her last visit of the NCT00122681 study (Visit 10, Month 48) so that no cervical sample could be collected at that visit.
Exclusion
- A subject who displayed normal cervical cytology and who was negative for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48).
- A subject who had a cervical lesion at her last NCT00122681 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the NCT00122681 exit colposcopy.
- A subject for whom the cervical cytology results from the last NCT00122681 study visit (Visit 10, Month 48) were unavailable for reasons other than pregnancy.
- If at the time of enrolment the subject experiences heavy bleeding (menstruation or other) or heavy vaginal discharge, or is pregnant, the pelvic exam cannot be performed. The subject's first study visit will be deferred until condition is resolved according to investigator's medical judgment.
Key Trial Info
Start Date :
August 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2014
Estimated Enrollment :
2022 Patients enrolled
Trial Details
Trial ID
NCT00937950
Start Date
August 5 2009
End Date
January 20 2014
Last Update
October 29 2019
Active Locations (83)
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1
GSK Investigational Site
Clearwater, Florida, United States, 33759
2
GSK Investigational Site
Miami, Florida, United States, 33136
3
GSK Investigational Site
Honolulu, Hawaii, United States, 96826
4
GSK Investigational Site
Iowa City, Iowa, United States, 52242