Trial of treatment of vaginal intraepithelial neoplasia (VAIN)

• Register: ISRCTN
• Last refreshed on: 27 November 2017
• Main ID: ISRCTN23349576
• Date of registration: 18/01/2016
• Prospective Registration: No
• Primary sponsor: Helsinki University Hospital, Women's Hospital
• Public title: Trial of treatment of vaginal intraepithelial neoplasia (VAIN)
• Scientific title: Randomized trial of treatment of vaginal intraepithelial neoplasia (VAIN): laser vaporization and imiquimod
• Date of first enrolment: 01/01/2016
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN23349576
• Study type: Interventional
• Study design: Single center randomized interventional trial (Treatment)

Countries of recruitment

Finland

Contacts

• Name: Annika Riska

Key inclusion & exclusion criteria

Inclusion criteria: 1. Over 18 years of age
2. Histological diagnosis of VAIN 2-3
3. Histological diagnosis of VAIN 1, which has been expectantly managed for two years
Exclusion criteria: 1. Pregnancy or lactation
2. Lack of reliable contraception in premenopausal patients
3. Known HIV infection
4. Vaginal cancer

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Vaginal intraepithelial neoplasia (VAIN)
Cancer
Vaginal intraepithelial neoplasia (VAIN)

Intervention(s)

Patients enrolled in the study will have an HPV sample taken (with a brush) in addition to the routine samples during an outpatient colposcopy visit. Enrolled patients will be randomized into two groups:

Group 1: treated by laser ablation
Group 2: treated with vaginally administered imiquimod

The imiquimod is given as suppositories which are used at home 1-2 times a week for two months (the single dose of imiquimod is 12.5 mg which can be halved if severe side effects occur). The follow-up in the study includes visits at the colposcopy clinic at 2, 4 and 6 months after the initial visit. If persistence or progression of the lesion is detected at the 4-month-visit, the patient is offered either laser ablation or surgery for treatment.

Primary Outcome(s)

1. Histological regression (defined as VAIN 1 or less), assessed from punch biopsies
2. HPV clearance, assessed via HPV genotyping from cervical or vaginal brush samples

Measured at 2, 4 and 6 months

Secondary Outcome(s)

1. Complete histological regression, assessed from punch biopsies
2. Tolerability of treatment, assessed based on adverse effect reporting on a standardized form from the patients

Measured at 2, 4 and 6 months

Secondary ID(s)

N/A

Source(s) of Monetary Support

Terveyden Tutkimuksen Toimikunta