Efficacy and safety of intravaginal application of SAM vaginal gel on suspicious cervical smear results and on CIN 1 and CIN 2 lesions

Not Applicable

Completed

• Conditions: Cervical intraepithelial neoplasia; Urological and Genital Diseases; Dysplasia of cervix uteri

• Registration Number: ISRCTN11009040
• Lead Sponsor: Deflamed International s.r.o.

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33219482/ results (added 23/11/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34113633/ (added 14/06/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37373835/ (added 28/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-01-29
• Study Start: 2019-12-10
• Last Update Posted: 10 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 216

Inclusion Criteria

1. Female patients
2. Age 25 - 60 years
3. Histological diagnosis of CIN 1 or cytological ASC H, ASC US, LSIL associated with a positive cytological p16 or histological p16 test, or CIN 2 or HSIL
4. Signed informed consent
5. Negative pregnancy test
6. Suitable method of contraception during the treatment period for women of childbearing potential

Exclusion Criteria

1. Oncological or immunological disease
2. Chronic viral disease (incl. hepatitis)
3. Immunosuppressive treatment
4. Pregnancy or breastfeeding
5. Known allergy to the gel or one of its components
6. Colposcopic finding suspicious of invasive disease
7. Simultaneous participation at another clinical trial
8. For CIN 2 patients, unsatisfactory colposcopy (i.e. the transformation zone and/or the lesion is not fully visible)
9. For CIN 1 patient, risk discrepancy with cytological finding (HSIL)

Study & Design

• Study Type: Interventional
• Study Design: Not specified