Status:
COMPLETED
ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial
Lead Sponsor:
Medical University of Vienna
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
PHASE3
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%)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00941252
Start Date
July 1 2009
End Date
January 1 2011
Last Update
January 24 2011
Active Locations (1)
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1
Medical University of Vienna, Dpt. of General Gynecology and Gynecologic Oncology
Vienna, Austria, 1090