Papillomavirus Infections Clinical Trial
Official title:
Gardasil Vaccination as Therapy in Low Grade Cervical Abnormalities
Verified date | July 2008 |
Source | Eisenhower Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 300 |
Est. completion date | July 2009 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 26 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Eisenhower Army Medical Center | Fort Gordon | Georgia |
Lead Sponsor | Collaborator |
---|---|
Eisenhower Army Medical Center |
United States,
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