Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities (NCT00501189) | Clinical Trial Compass
WithdrawnNot Applicable
Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities
Stopped: recruiting issues
United States0Started 2007-08
Plain-language summary
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.
Who can participate
Age range
18 Years – 26 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.