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.
Conditions
Interventions
Product Name: Aldara
Product Code: EU/1/98/080/001-002
Pharmaceutical Form: Vaginal capsule, soft
INN or Proposed INN: IMIQUIMOD
CAS Num
Sponsors
Medizinische Universität Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study investigates the non-inferiority of the new treatment, compared to surgical standard treatment. The primary endpoint is the rate of successful treatment, defined as negative HPV test result six months after treatment start. Six months after start of therapy the primary study endpoint is assessed using HPV genotyping (cobas® 4800 HPV Test, Roche). In addition clinical examinations including colposcopy, HPV genotyping, PAP smear, and if indicated colposcopy-guided biopsies of the uterine cervix will be performed. ;Secondary Objective: In addition, rates of CIN persistence/recurrence 6, 12, 18, and 24 months after treatment start and rates of negative HPV test results 12 and 24 months after treatment start will be evaluated in both treatment groups. ;Primary end point(s): Non inferiority of the new treatment. Successful treatment is defined as negative HPV test result 6 months after treatment start (assessed by cobas® 4800 HPV Test, Roche);Timepoint(s) of evaluation of this end point: Six months after treatment start | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Intention-to-treat non-inferiority analyses of rates of CIN persistence/recurrence 6,12, 18 and 24 months after treatment start (based on Cytology and/or Histology results) 2) Intention to treat non-inferiority analyses of rates of negative HPV test results 12 and 24 months after treatment start 3) Per-protocol non-inferiority analyses of negative HPV test results at 6, 12 and 24 months after treatment start, and rates of CIN persistence/recurrence 6, 12, 18 and 24 months after treatment start 4) Intention-to-treat non-inferiority analyses of negative HPV test results according to HPV16/18 infection ;Timepoint(s) of evaluation of this end point: 12, 18, and 24 months after treatment start | — |
Countries
Austria
Contacts
Public ContactAbteilung für Gynäkologie, AKH Wien
Medizinische Universität Wien
Outcome results
None listed