Topical Imiquimod Versus Conization to Treat Cervical Intraepithelial Neoplasia

• Status: Terminated
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to investigate the non-inferiority of a topical Imiquimod therapy in patients with persistent CIN 2/3 when compared to standard therapy, i.e. conization A randomized, controlled, non-inferiority AGO-Austria trial

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Collaborators: Krankenhaus Barmherzige Schwestern Linz; Medical University Innsbruck; Medical University of Graz; Salzburger Landeskliniken
• Treatments: Imiquimod

Criteria

Inclusion criteria:

1. Women aged ≥18 years diagnosed with histologically verified CIN 3 and women aged ≥ 30 years diagnosed with CIN 2

2. Satisfactory colposcopy

3. Signed informed consent

4. Negative pregnancy test

5. Appropriate contraception method for fertile women during active study period

6. Adequate compliance

Exclusion criteria:

1. Adenocarcinoma in situ

2. History of previous conization

3. Malignant disease at the time of inclusion

4. Colposcopy suspicious for invasive disease

5. Pregnancy and lactation period

6. Known allergy or intolerance to IMQ

7. Contraindications to conization or IMQ

8. Symptoms of a clinically relevant disease

9. Known HIV infection

10. Evidence of a clinically significant immunodeficiency

11. Current, reported participation in another experimental, interventional protocol