Cervical intraepitelial neoplasia (CIN)
Conditions
Interventions
1:100 mg / day (1 suppository with placebo and one suppository 100 mg per day)
2:200 mg / day (1 suppository 100 mg 2 times a day)
3:one with placebo suppository 2 times a day
Sponsors
CJSC “IlmixGroup”
Eligibility
Sex/Gender
Female
Age
18 Years to 39 Years
Inclusion criteria
Inclusion criteria: 1. a written informed consent to participate in this study; 2. histologically verified cervical intraepithelial neoplasia grade 1-2 (CIN1-CIN2); 3. age 18-39 years; 4. ability to perform the procedures provided for the study protocol; 5. no dependence on the persons involved in research and interested in its outcome; 6. agreement to use a barrier method of contraception (condoms) for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. hypersensitivity to the drug; 2. areas of dysplasia of cervical epithelium of less than 1.5 cm^2; 3. severe concomitant diseases of the cardiovascular and nervous systems, mental illness, kidney and liver failure, or other serious illness, and / or physical conditions, which, according to the investigator opinion, makes patient impossible to participate in the study; 4. infections of the genitourinary system in the phase of active inflammation 5. cervical intraepithelial neoplasia grade 3 (CIN3), or cancer in situ; 6. positive tests RW or HIV; 7. alcohol or drug abuse; 8. malignant tumors of any localization; 9. receipt of any investigational drug within 30 days or five half-lives (depending on which value is greater) to the first dose of study medication; 10. pregnancy, breast-feeding; 11. virginity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with complete regression of CIN 3 or 6 months after the beginning of the drug Cervikon-DIM; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with partial regression of CIN 3 or 6 months after the beginning of the drug Cervikon-DIM.; | — |
Countries
Russia
Contacts
Public ContactLevon Ashrafian
Outcome results
None listed