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ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT00941252
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
18
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Topical imiquimod therapy
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia
Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Imiquimod

topical therapy for 16 weeks with imiquimod containing therapy

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)
Other Names:
  • Aldara

    		•
    Placebo Comparator: Placebo

    topical therapy for 16 weeks with a placebo containing vaginal suppository

    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)
    Other Names:
  • Aldara

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3 [20 weeks after treatment start]

    Secondary Outcome Measures

    1. HPV-Clearance, feasibility and adverse event profile and drop-out rate [20 weeks after treatment start]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    • Principal Investigator: Paul Speiser, MD, Medical University of Vienna

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00941252
    Other Study ID Numbers:
    • ITIC1.0
    First Posted:
    Jul 17, 2009
    Last Update Posted:
    Jan 24, 2011
    Last Verified:
    Jan 1, 2011
    Additional relevant MeSH terms:
    Neoplasms
    Carcinoma in Situ
    Cervical Intraepithelial Neoplasia
    Imiquimod

    Study Results

    No Results Posted as of Jan 24, 2011