A randomized, single blinded trial to evaluate the efficacy of Imiquimod in women with residual/recurrent Cervical Intraepithelial Neoplasia (CIN) after previous treatment
- Conditions
- gynaecologische afwijkingen, CIN afwijkingenCervical Intraepithelial Neoplasiaprecancereous leasions of the cervix1006291510029903
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 433
- Histologically proven CIN2 or CIN 3, without invasion after previous surgical treatment at least 6 months before diagnosis
- Histologically proven persistent CIN 1 after previous surigcal treament at least 6 months before diagnosis. Persistent CIN 1 is defined as CIN 1 at least persistent for 6 months and proven with histology
- The patient is willing to use a medically acceptable method of contraception throughout the study
- Women older than 18 years of age
- Pregnancy or lactation
- (Micro-)invasive carcinoma
- Past history of cervical cancer
- Hypersensitivity of any components of the formulation
- History of psoriasis or other inflammatory dermatosis of the vulva
- Immunodeficiency or treatment with immunosuppressive medication
- Insufficient understanding of the Dutch or English language
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome: Reduction to normal cytology 6 months after treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes: Reduction to no dysplasia 10 weeks after the treatment in<br /><br>the imiquimod group, presence or absence of HPV DNA in CIN lesions before and<br /><br>after treatment, tolerability to the treatment, quality of life and durability<br /><br>of the clinical response at 6, 12 and 24 months after the final treatment, time<br /><br>between treatment and conversion from hrHPV positivity, acceptability of<br /><br>self-sampling method with urine.</p><br>