Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects

Completed · Phase 3 · Has a placebo group

Conditions studied: Infections, Papillomavirus

In brief

This study is intended to provide up to a maximum of four years of annual oncogenic human papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their concluding NCT00294047 study visit. Women who were pregnant at their concluding NCT00294047 study visit may also be included in this study, as no cervical sample could be collected at that visit. The objectives and outcome measures of the primary phase (NCT00294047) are presented in a separate protocol posting.

Key facts

Study ID

NCT01190176

Run by

GlaxoSmithKline

People needed

34

Starts

2011-09-12

Expected to finish

2017-09-20

Last updated by the study team

2019-10-30

Who can join

Age: 28 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.
• A subject previously enrolled in the study NCT00294047 and who fulfils either of the following criteria:
• displayed normal cervical cytology but tested positive for oncogenic HPV infection at her concluding NCT00294047 study visit
• was pregnant so that no cervical sample could be collected at her concluding NCT00294047 study visit

You may not qualify if…

• A subject who at the NCT00294047 concluding study visit displayed normal cervical cytology and who was negative for oncogenic HPV infection at that visit.
• A subject who at the NCT00294047 concluding study visit had a cervical lesion at that visit or who had a cervical lesion that required treatment at her NCT00294047 exit colposcopy.
• A subject for whom the cervical cytology results from the concluding NCT00294047 study visit were unavailable for reasons other than pregnancy.

Where it is running

• GSK Investigational Site — Iowa City, Iowa, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Wenatchee, Washington, United States
• GSK Investigational Site — Edmonton, Alberta, Canada
• GSK Investigational Site — Vancouver, British Columbia, Canada
• GSK Investigational Site — Halifax, Nova Scotia, Canada
• GSK Investigational Site — Truro, Nova Scotia, Canada
• GSK Investigational Site — Sherbrooke, Quebec, Canada
• GSK Investigational Site — Amsterdam, Netherlands
• GSK Investigational Site — Rotterdam, Netherlands
• GSK Investigational Site — Almada, Portugal
• GSK Investigational Site — Coimbra, Portugal
• GSK Investigational Site — Lisbon, Portugal
• GSK Investigational Site — Setúbal, Portugal
• GSK Investigational Site — Moscow, Russia
• GSK Investigational Site — Saint Petersburg, Russia
• GSK Investigational Site — Singapore, Singapore
• GSK Investigational Site — Singapore, Singapore
• GSK Investigational Site — London, United Kingdom
• GSK Investigational Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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