Topical Imiquimod Compared with Conization to Treat Cervical Intraepithelial Neoplasia
- Conditions
- In this randomized controlled, multi-center trial we will investigate the non-inferiority of a topical IMQ treatment compared to surgical standard treatment in selected patients diagnosed with CIN 2/3.Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2012-004518-32-AT
- Lead Sponsor
- Medizinische Universität Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
1)Women aged =18 years diagnosed with histologically verified CIN 3 and women aged = 30 years diagnosed with CIN 2
2)Satisfactory colposcopy
3)Signed informed consent
4)Negative pregnancy test
5)Appropriate contraception method for fertile women during active study period
6)Adequate compliance
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 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1)Adenocarcinoma in situ
2)History of previous conization
3)Malignant disease at the time of inclusion
4)Coploscopy suspicious for invasive disease
5)Pregnancy and lactation period
6)Known allergy or intolerance to IMQ
7)Contraindications to conization or IMQ
8)Symptoms of a clinical relevant disease
9)Known HIV infection
10)Evidence of a clinically significant immunodeficiency
11)Participation in another experimental, interventional, protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method