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

Completed · Phase 3

Conditions studied: Infections, Papillomavirus

In brief

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).

Key facts

Study ID

NCT00937950

Run by

GlaxoSmithKline

People needed

2022

Starts

2009-08-05

Expected to finish

2014-01-20

Last updated by the study team

2019-10-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not 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 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Honolulu, Hawaii, United States
• GSK Investigational Site — Iowa City, Iowa, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Bardstown, Kentucky, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Chapel Hill, North Carolina, United States
• GSK Investigational Site — New Bern, North Carolina, United States
• GSK Investigational Site — Tulsa, Oklahoma, United States
• GSK Investigational Site — Portland, Oregon, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Pleasant Hills, Pennsylvania, United States
• GSK Investigational Site — Wenatchee, Washington, United States
• GSK Investigational Site — Westmead, New South Wales, Australia
• GSK Investigational Site — Hobart, Tasmania, Australia
• GSK Investigational Site — Carlton, Victoria, Australia
• GSK Investigational Site — Parkville, Victoria, Australia
• GSK Investigational Site — Perth, Western Australia, Australia
• GSK Investigational Site — Brussels, Belgium
• GSK Investigational Site — Edegem, Belgium
• GSK Investigational Site — Clearwater, Florida, United States

Full record on ClinicalTrials.gov

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