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

Primary Purpose

Cervical Intraepithelial Neoplasia

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Topical imiquimod therapy
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Imiquimod

Placebo

Arm Description

topical therapy for 16 weeks with imiquimod containing therapy

topical therapy for 16 weeks with a placebo containing vaginal suppository

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2009
Last Updated
January 21, 2011
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00941252
Brief Title
ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial
Acronym
ITIC
Official Title
Topical Imiquimod in Treating Patients With Grade 2/3 Cervical Intraepithelial Neoplasia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imiquimod
Arm Type
Active Comparator
Arm Description
topical therapy for 16 weeks with imiquimod containing therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
topical therapy for 16 weeks with a placebo containing vaginal suppository
Intervention Type
Drug
Intervention Name(s)
Topical imiquimod therapy
Other Intervention Name(s)
Aldara
Intervention Description
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)
Primary Outcome Measure Information:
Title
To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3
Time Frame
20 weeks after treatment start
Secondary Outcome Measure Information:
Title
HPV-Clearance, feasibility and adverse event profile and drop-out rate
Time Frame
20 weeks after treatment start

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Speiser, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
22914404
Citation
Grimm C, Polterauer S, Natter C, Rahhal J, Hefler L, Tempfer CB, Heinze G, Stary G, Reinthaller A, Speiser P. Treatment of cervical intraepithelial neoplasia with topical imiquimod: a randomized controlled trial. Obstet Gynecol. 2012 Jul;120(1):152-9. doi: 10.1097/AOG.0b013e31825bc6e8.
Results Reference
derived

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ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

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