Efficacy of DeflaGyn® vaginal gel in the treatment of suspicious cervical smear findings, related histopathological diagnoses CIN1 and CIN2 and the hr-HPV status: a post marketing clinical follow-up study.

Phase 4

• Conditions: R87.6; N87.0; Mild cervical dysplasia

• Registration Number: DRKS00030569
• Lead Sponsor: Exeltis Germany GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 70

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Regression of cytological findings according to Bethesda Classification<br>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.<br>

Secondary Outcome Measures

Name	Time	Method
Regression of cervical intraepithelial neoplasia CIN1 and CIN2.<br>Clearance of hr-HPV infections. Safety evaluation.<br>