CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,022 enrolled
Drug / intervention
Gynaecological follow-upother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT00937950
NCT00937950Phase 3Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Jul 13, 2009·Updated Oct 29, 2019

In Brief

A Phase 3 clinical trial evaluating Gynaecological follow-up for Infections, Papillomavirus. Completed, enrolled 2,022 participants across 83 sites in 13 countries.

Detailed 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 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Papillomavirus
CountriesAustralia, Belgium, Brazil, Canada, Finland, Germany, Italy, Philippines, Spain, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2009
Enrollment StartAug 5, 2009
Primary CompletionJan 20, 2014
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.0 years ago

Interventions

Gynaecological follow-upother

Subjects received a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years in this gynaecological follow-up study (HPV-052 EXT 008). No vaccine was administered in this extension study. Subjects received 3 doses of Cervarix/Havrix vaccine, administered intramuscularly, according to a 0, 1, 6-month vaccination schedule in the HPV-008 (NCT00122681) primary study.