Trial of treatment of vaginal intraepithelial neoplasia (VAIN).

Conditions: VAIN, vaginal intraepithelial neoplasia
MedDRA version: 18.1Level: PTClassification code 10046890Term: Vaginal cancer stage 0System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2016-000746-59-FI

Lead Sponsor: HYKS Naistensairaala

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

- histologically confirmed VAIN grade 1 that has persisted for two years or histologically confirmed VAIN grade 2-3
- age > 18
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- vaginal cancer
- pregnancy or lactation
- lack of reliable contraception in premenopausal subjects
- known allergy to imiquimod
- HIV positivity

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the trial is to evaluate the effectiveness and tolerability of treatment in VAIN comparing conventional laser vaporization to vaginally administered imiquimod.;Secondary Objective: To assess HPV clearance with the different treatments.;Primary end point(s): Histological regression to VAIN 1 or less.;Timepoint(s) of evaluation of this end point: 8, 16, 32 weeks.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Complete histological regression, HPV clearance and tolerability of the treatment.;Timepoint(s) of evaluation of this end point: 8, 16, 32 weeks.