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NCT01190176 · ClinicalTrials.gov registry record · Phase 3
Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 34
- Enrollment target
NCT01190176: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01190176 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 34 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01190176, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 34 participants
- Enrollment target
Study Summary
This study is intended to provide up to a maximum of four years of annual oncogenic human papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their concluding NCT00294047 study visit. Women who were pregnant at their concluding NCT00294047 study visit may also be included in this study, as no cervical sample could be collected at that visit. The objectives and outcome measures of the primary phase (NCT00294047) are presented in a separate protocol posting.
Primary Outcome
Subjects with 2 positive oncogenic HPV DNA tests or 1 cervical cytology reading ≥ASC-US (atypical squamous cells of undetermined significance) positive for oncogenic HPV DNA or 1 cervical cytology reading ≥LSIL (low grade squamous intraepithelial lesion) were referred for colposcopy evaluation according to the clinical management algorithm.
Interventions
- PROCEDURE Gynaecological follow-up
- BIOLOGICAL Cervarix
- BIOLOGICAL Placebo control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2011-09-12 |
| Est. Completion | 2017-09-20 |
| Phase | Phase 3 |
What the finished NCT01190176 record still lists
NCT01190176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Gynaecological follow-up is the first listed.
NCT01190176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01190176 about?
NCT01190176 is a clinical study titled "Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects". This study is intended to provide up to a maximum of four years of annual oncogenic human papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their concluding NCT00...
What is the current status of trial NCT01190176?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2011-09-12. Estimated completion is 2017-09-20.
What interventions are being tested in trial NCT01190176?
The interventions under investigation include: Gynaecological follow-up (PROCEDURE), Cervarix (BIOLOGICAL), Placebo control (BIOLOGICAL).
Who is sponsoring clinical trial NCT01190176?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01190176's enrollment target sits among peer trials
34 1905th of 2000 higher than 94 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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