Gynaecological Follow-up of a Subset of 580299/008 Study Subjects
Gynaecological Follow-up of a Subset of 580299/008 Study Subjects
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 tested positive for oncogenic HPV infection at their last NCT00122681 study visit (Visit 10, Month 48).
This follow-up study will also be offered to subjects who were pregnant at their last NCT00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at that visit.
The objectives & outcome measures of the primary phase (study 008/580299) are presented in a separate protocol posting (NCT00122681).
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:
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:
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.
Los Banos, Laguna, 4027, Philippines
Móstoles/Madrid, 28935, Spain