A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

Phase 3

Completed

• Conditions: Cervical cancer; Human Papillomavirus infection; 10047438; 10038594; 10013364

• Registration Number: NL-OMON38130
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

- A subjects previously enrolled in the HPV-015 study
- A subject with normal cervical cytology but positive test result for oncogenic HPV infection at concluding HPV-015 study visit
- A subject that was pregnant so that no cervical sample could be collected at concluding HPV-015 study visit

Exclusion Criteria

- A subject with normal cervical cytology and negative test result for oncogenic HPV infection at concluding HPV-015 study visit
- A subject with a cervical lesion or with a cervical lesion that required treatment at concluding HPV-015 study visit
- A subject for whom the cervical cytology results were unavailable for reasons other than pregnancy at concluding HPV-015 study visit

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Occurrence of positive oncogenic HPV DNA results in cervical samples by HPV<br /><br>DNA testing (Hybrid Capture® 2 test [HC2])<br /><br>- Occurrence of cervical cytological abnormalities in cervical samples by<br /><br>ThinPrep® PapTest<br /><br>- Occurrence of referral to colposcopy<br /><br>- Occurrence of referral to treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>