Phase 3 N=2,003 Prevention

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

Infections, Papillomavirus

Bottom Line

View on ClinicalTrials.gov: NCT00937950 ↗

Enrolled (actual)

2,003

Serious AEs

0.0%

Results posted

Jan 2015

Primary outcome: Primary: Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII) — 615; 828; 24; 418 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Gynaecological follow-up (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: GlaxoSmithKline
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With HPV DNA in Cervical Samples by Hybrid Capture 2 Test (HCII)	615; 828; 24; 418; 444; 7	—
PRIMARY Number of Subjects With Colposcopy Referral and Colposcopy Adequacy	572; 1429; 2; 371; 21; 370	—
PRIMARY Number of Subjects With Cytological Abnormalities in Cervical Samples by ThinPrep PapTest	1193; 154; 8; 100; 8; 4	—
PRIMARY Number of Subjects With Cervical Biopsy Results at Month 12	76; 41; 158; 18; 181; 8	—
PRIMARY Number of Subjects With Cervical Biopsy Results at Month 24	38; 47; 100; 8; 139; 8	—
PRIMARY Number of Subjects With Cervical Biopsy Results at Month 36	31; 31; 57; 6; 82; 3	—
PRIMARY Number of Subjects With Cervical Biopsy Results at Month 48	21; 15; 39; 5; 49; 2	—
PRIMARY Number of Subjects With Treatment Referrals by Treatment Type at Month 12	33; 359; 14; 18; 15; 17	—
PRIMARY Number of Subjects With Treatment Referrals by Treatment Type at Month 24	19; 243; 1; 9; 8; 4	—
PRIMARY Number of Subjects With Treatment Referrals by Treatment Type at Month 36	13; 145; 4; 6; 4; 6	—
PRIMARY Number of Subjects With Treatment Referrals by Treatment Type at Month 48	9; 87; 1; 7; 5; 3	—
PRIMARY Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Withdrawal	216	—
PRIMARY Number of Subjects With Any Fatal SAEs, With Any SAEs Assessed as Possibly Related to Study Participation or to a Concurrent GSK Medication.	0; 0; 0	—

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).

Eligibility Criteria

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:
displayed normal cervical cytology but tested positive for oncogenic HPV infection at her last NCT00122681 study visit (Visit 10, Month 48).

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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00937950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.