Topical Imiquimod in Treating Patients with Grade 2/3 Cervical Intraepithelial Neoplasia - ITIC (Imiquimod Therapy in Cervical Intraepithelial Neoplasia)-Trial

Phase 1

• Conditions: Grade 2/3 Cervical Intraepithelial Neoplasia; MedDRA version: 9.1Level: LLTClassification code 10049701Term: Cervical intraepithelial neoplasia II; MedDRA version: 9.1Level: LLTClassification code 10049702Term: Cervical intraepithelial neoplasia III

• Registration Number: EUCTR2008-007763-16-AT
• Lead Sponsor: Medizinische Universität Wien, Univ.Klinik f.Frauenheilkunde,Abt. f.Gynäkologie und Gyn.Onkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-26
• Last Update Posted: 5 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Participance in another clinical trial within 30 days

Malignancy

Immunosuppression (medication, illness)

HIV- or Hepatitis infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of topical treatment with Imiquimod in patients with CIN 2/3.;Secondary Objective: HPV-Clearance, feasability and adverse event profile and drop-out rate;Primary end point(s): Primary endpoint:<br><br>Is a topical treatment with imiquimod for 16 weeks in women with CIN 2/3 efficiant?