Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects

Launched by GLAXOSMITHKLINE · Jul 9, 2009

Keywords

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.