Trial of treatment and follow-up of vaginal intraepithelial neoplasia (VAIN)

Not Applicable

Completed

• Conditions: Vaginal intraepithelial neoplasia (VAIN); Urological and Genital Diseases; Vaginal intraepithelial neoplasia [VAIN], grade I

• Registration Number: ISRCTN45751386
• Lead Sponsor: Helsinki University Central Hospital (Finland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-15
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. A biopsy-confirmed VAIN1 that has persisted for two years or biopsy-confirmed VAIN2-3
2. Previously laser or surgically treated VAIN, when previous treatment has occurred over 1 month prior
3. Immune compromised patients (i.e. patients with rheumatoid arthritis, scleroderma, etc.) who frequently have VAIN
4. Patients of legal age (18 years old and above)

Exclusion Criteria

1. Vaginal carcinoma
2. Pregnancy or breast-feeding
3. Lack of reliable contraception in premenopausal patients
4. Known allergy to imiquimod
5. Language difficulties (patients who do not speak sufficient Finnish or English)
6. Simultaneous need for Loop Electrosurgical Excision Procedure (LEEP)
7. HIV positive

Study & Design

• Study Type: Interventional
• Study Design: Not specified