Treatment of high-grade Cervical Intraepithelial Neoplasia with imiquimod or surgery.

Phase 1

• Conditions: High-grade Cervical Intraepithelial Neoplasia; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2016-002096-96-NL
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-07
• Last Update Posted: 26 September 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- de novo CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy
- age of 18 years or older
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 140
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- previous histologically confirmed high-grade CIN (CIN 2–3)
- concomitant vulvar and/or vaginal intraepithelial neoplasia
- previous cervical malignancy
- current malignant disease
- immunodeficiency (including HIV/AIDS and immunodepressive medication)
- pregnancy or lactation
- legal incapability

Study & Design

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