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ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cervical Intraepithelial Neoplasia

Intervention: Topical imiquimod therapy (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Paul Speiser, MD, Principal Investigator, Affiliation: Medical University of Vienna

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3

Secondary outcome: HPV-Clearance, feasibility and adverse event profile and drop-out rate

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology, Vienna 1090, Austria
Additional Information

Starting date: July 2009
Last updated: January 21, 2011

Page last updated: August 23, 2015

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