Clinical Trials

Sponsor(s): Medical University of Vienna

Condition(s):

Cervical Cancer
Cervical Dysplasia
Cancer
Cervical Intraepithelial Neoplasia
Neoplasms

Purpose: The present primary therapy of cervical intraepithelial neoplasia (CIN) grade 3 and persistent CIN 2 represents conisation. Surgical treatment can cause perioperative (infection, bleeding in in 5-10%) and postoperative (increased risk of preterm labor) complications, as well as incomplete resections (20%) and risk of recurrence in 5-17%. Imiquimod is an immunomodulating drug, that has been reported to be effective in human papilloma virus-related disease, such as vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VAIN), and anal intraepithelial neoplasia (AIN). The present randomised, placebo controlled, double blind study evaluates the efficacy of a topical treatment with imiquimod for 16 weeks in 60 patients with histologically confirmed CIN 2/3.

Eligibility:

Minimum Age:

18 Years

Maximum Age:

80 Years

Accepts Healthy Volunteers:

No

Inclusion Criteria:

- Caucasian women aged 18 years and older with proven HPV-associated CIN 2/3

- Colposcopy with fully visible transformation zone and lesion

- Safe Contraception

- Signed Informed Consent

- Negative urine pregnancy test

- Able to communicate well with the investigator, to understand and comply with the
requirements of the study

- Signed the written informed consent

Exclusion Criteria:

- Women who are pregnant or lactating or become pregnant during the conduct of the
study

- Symptoms of a clinically relevant illness in the 3 weeks before the first study day

- History of hypersensitivity to the trial drug or to drugs with a similar chemical
structure

- Participating in another clinical trial within 30 days

- Malignancy

- Immunosuppression (medication, illness)

- HIV- or Hepatitis infection

Other Location(s): Vienna, Austria

Terms: This is an abstract courtesy of ClinicalTrials.gov, a service of the US National Institute of Health Developed by the National Library of Medicine. ClinicalTrials.gov provides regularly updates information about federally and privately supported clinical research in human volunteers.