Clinical trial · Observational
Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities
NCT00501189CI-TRIAL-00077862withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): recruiting issues
Summary
Brief summary (as posted)
This project will compare the rate of regression of minimally abnormal Pap smears to normal in women who receive Gardasil to a historical control group. Research hypothesis: Women with low grade cervical dysplasia on Papanicolaou (Pap) smear that receive Gardasil vaccination will revert to a normal within one year at a rate 33% higher than historical controls that did not receive Gardasil vaccination.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papillomavirus Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| human papillomavirus vaccine L1, type 6,11,16,18 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- Those getting Gardasil vaccination for low grade Pap abnormality.
- interventionNames
- Biological: human papillomavirus vaccine L1, type 6,11,16,18
- label
- 2
- description
- Historical group that did not get Gardasil.
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: * Women between 18 and 26 years of age * Women able to consent for themselves * Referring Pap smear was ASCUS, + HPV or LGSIL * Women who decide they wish to get the Gardasil vaccination series Exclusion Criteria: * Women who have had previous cryotherapy of the cervix, LEEP or cervical conization * Women who had their first Gardasil injection prior to their referring Pap smear * Women under the age of 18 * Women unable to consent for themselves * Women who are pregnant currently trying to conceive * Women in an immunocompromised state (diabetes, HIV, on chronic immunosuppressants or steroids, etc) * Women who do not want the Gardasil vaccination series
References
Publications (0)
Data not yet available
No reference posted for this study.