Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
Trial overview
Number of subjects reporting positive oncogenic HPV DNA results by Hybrid Capture II test (HCII) at Month 12
Timeframe: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects reporting positive oncogenic HPV DNA results by Hybrid Capture II test (HCII) at Month 24
Timeframe: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects reporting positive oncogenic HPV DNA results by Hybrid Capture II test (HCII) at Month 36
Timeframe: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects reporting positive oncogenic HPV DNA results by Hybrid Capture II test (HCII) at Month 48
Timeframe: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects with any cytological abnormalities in cervical samples by ThinPrep PapTest at Month 12
Timeframe: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects with any cytological abnormalities in cervical samples by ThinPrep PapTest at Month 24
Timeframe: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects with any cytological abnormalities in cervical samples by ThinPrep PapTest at Month 36
Timeframe: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects with any cytological abnormalities in cervical samples by ThinPrep PapTest at Month 48
Timeframe: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects with referral to colposcopy at Month 12
Timeframe: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects with referral to colposcopy at Month 24
Timeframe: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects with referral to colposcopy at Month 36
Timeframe: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects with referral to colposcopy at Month 48
Timeframe: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects with referral to treatment at Month 12
Timeframe: At Month 12 [12 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects with referral to treatment at Month 24
Timeframe: At Month 24 [24 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects with referral to treatment at Month 36
Timeframe: At Month 36 [36 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Number of subjects with referral to treatment at Month 48
Timeframe: At Month 48 [48 months post concluding HPV-015 visit (Visit 9, Visit 11 or last HPV-015 study visit)]
Participation 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.
- 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.
- 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
Written informed consent obtained from the subject prior to enrolment.
- 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.
A subject who at the NCT00294047 concluding study visit displayed normal cervical cytology and who was negative for oncogenic HPV infection at that visit.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.