Gynaecological Follow-up of a Subset of 580299/008 (NCT 00122681) Study Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00937950
First received: July 2, 2009
Last updated: August 14, 2014
Last verified: May 2014

July 2, 2009
August 14, 2014
August 2009
January 2014   (final data collection date for primary outcome measure)
  • Evaluation of the presence of oncogenic HPV DNA in cervical samples by HPV DNA testing [ Time Frame: Every 12 months, until treatment of cytological abnormality is required, until negative oncogenic HPV DNA test and normal cervical cytology or for up to 4 years, which ever comes first ] [ Designated as safety issue: No ]
  • Evaluation of cervical cytological abnormalities in cervical samples [ Time Frame: Every 12 months, until treatment of cytological abnormality is required, until negative oncogenic HPV DNA test and normal cervical cytology or for up to 4 years, which ever comes first ] [ Designated as safety issue: No ]
  • Occurrence of referral to colposcopy. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Evaluation of colposcopy outcomes and biopsy results according to local laboratories. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Occurrence of referrals to treatment. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Evaluation of local cervical therapy performed and treatment biopsy results according to local laboratories. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Occurrence of fatal SAEs. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Occurrence and intensity of SAEs assessed as possibly related to study participation. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Occurrence and intensity of SAEs assessed as possibly related to a concurrent GSK medication. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Withdrawals from the study due to AEs and SAEs. [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00937950 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Gynaecological Follow-up of a Subset of 580299/008 (NCT 00122681) Study Subjects
Gynaecological Follow-up of a Subset of 580299/008 Study Subjects

This study is designed provide up to four years of annual oncogenic HPV DNA testing and cervical cytology examination for NCT 00122681 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their last NCT 00122681 study visit (Visit 10, Month 48).

This follow-up study will also be offered to subjects who were pregnant at their last NCT 00122681 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).

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Infections, Papillomavirus
Procedure: Gynaecological follow-up
Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to four years.
Experimental: Single group
NCT 00122681 study subjects who had normal cervical cytology but tested positive for oncogenic HPV at their final NCT 00122681 study visit (Visit 10 at Month 48) or were pregnant at their final NCT 00122681 study visit (Visit 10 at Month 48)
Intervention: Procedure: Gynaecological follow-up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2028
January 2014
January 2014   (final data collection date for primary outcome measure)

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 NCT 00122681 and who fulfils either of the following criteria:
  • displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last NCT 00122681 study visit (Visit 10, Month 48).

or

• was pregnant at her last visit of the NCT 00122681 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 NCT 00122681 study visit (Visit 10, Month 48).
  • A subject who had a cervical lesion at her last NCT 00122681 study visit (Visit 10, Month 48) or who had a cervical lesion that required treatment at the NCT 00122681 exit colposcopy.
  • A subject for whom the cervical cytology results from the last NCT 00122681 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.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Brazil,   Canada,   Finland,   Germany,   Italy,   Philippines,   Spain,   Taiwan,   Thailand,   United Kingdom
 
NCT00937950
112024
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP