R87.6 N87.0
Conditions
Interventions
Group 1: Low-intervention, open prospective multicentric, non-controlled post- market clinical follow up study to assess the efficacy of a vaginal gel containing silicon dioxide, citric acid and sodiu
Sponsors
Exeltis Germany GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female premenopausal patients between 35 and 50 years 2. Cytologic diagnosis ASC-US, ASC-H, LSIL or HSIL 3. Histologic Diagnosis of CIN1 or CIN2 4. Positive for hr-HPV 5. Written Informed Consent
Exclusion criteria
Exclusion criteria: 1. Oncological or immunological disease 2. Chronic viral disease 3. Immunosuppressive treatment 4. Pregnancy 5. Patients who are postmenopausal 6. Known Allergy to the gel or one of its components 7. Colposcopic finding conspicuous of invasive disease 8. Unsatisfactory colposcopy 9. For CIN1 patients: risk discrepancy with cytological findings (e.g. HSIL; ASC-H) 10. Benign or malignant gynecological changes of the vulva 11. Simultaneous participation at another clinical trial or during participation during the preceding 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Regression of cytological findings according to Bethesda Classification after treatment with DeflaGyn® vaginal gel at 6 and 12 months. Results will be compared to epidemiological data from literature to evaluate the efficacy of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Regression of cervical intraepithelial neoplasia CIN1 and CIN2. Clearance of hr-HPV infections. Safety evaluation. | — |
Countries
Germany
Contacts
Public ContactJörg Schreier
CTK Poliklinik GmbHMVZ Schreier/Burdack/EneCarl-Thiem-Klinikum
Outcome results
None listed