NCT00941252

ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
DRUG	Topical 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)

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-07-17
• Last updated: 2011-01-24

Locations

1 site across 1 country: Austria