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 range18 Years – 26 Years

SexFEMALE

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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

Trial details

NCT IDNCT00501189

SponsorEisenhower Army Medical Center

Sponsor typeFED

Study typeOBSERVATIONAL

Primary completion2007-09-01

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