Cervical Intraepithelial Neoplasia
Conditions
Brief summary
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.
Interventions
DRUGTopical imiquimod therapy
therapy consists of treatment with topical vaginal suppositories for 16 weeks, each vaginal suppository contains 6.25mg of imiquimod, frequency (one time a week in treatment week 1+2, two times a week in treatment week 3+4, three times a week in treatment week 5-16)
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3 | 20 weeks after treatment start |
Secondary
| Measure | Time frame |
|---|---|
| HPV-Clearance, feasibility and adverse event profile and drop-out rate | 20 weeks after treatment start |
Countries
Austria
Outcome results
None listed