Clinical Trial: ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Medical University of Vienna

Current Primary Outcome: To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3 [ Time Frame: 20 weeks after treatment start ]

Original Primary Outcome: Same as current

Current Secondary Outcome: HPV-Clearance, feasibility and adverse event profile and drop-out rate [ Time Frame: 20 weeks after treatment start ]

Original Secondary Outcome: Same as current

Information By: Medical University of Vienna

Dates:
Date Received: July 16, 2009
Date Started: July 2009
Date Completion:
Last Updated: January 21, 2011
Last Verified: January 2011