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

Randomised, prospective, open-label with control group clinical trial to investigate the efficacy and safety of the topical (intravaginal) application of the gel “SAM vaginal gel” (class IIa medical device) through the regression rate of cervical smears ASC US, ASC H, LSIL, and HSIL and cervical lesions CIN 1 and CIN 2 and through the regression of the marker p16

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11009040

Enrollment

222

Registered

2019-12-10

Start date

2017-02-14

Completion date

Unknown

Last updated

2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical intraepithelial neoplasia Urological and Genital Diseases Dysplasia of cervix uteri

Interventions

Patients will be randomised to either the active arm (vaginal gel group), or to the control arm (wait and watch). Patients in the active arm will receive 3 x 28-days package of vaginal gel on visit 1.

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
The clinically relevant primary endpoint was the regression rate comparison after three months of follow-up between patient groups using SAM vaginal gel (DeflaGyn®) and “watch and wait” patient (control group), where the regression rate was defined as the combined endpoint of cytology and histology. Success was regarded as either cytological regression, defined as an initial ASC-US, LSIL, ASC-H or HSIL disappeared or changed to lower level (e.g. LSIL to ASC-US etc.) after treatment OR histological regression; defined as an initial CIN 1 lesion disappeared after treatment, or as an initial CIN 2 lesion replaced by CIN 1 lesion or disappeared after treatment, respectively.	—

Measure

Time frame

The clinically relevant primary endpoint was the regression rate comparison after three months of follow-up between patient groups using SAM vaginal gel (DeflaGyn®) and “watch and wait” patient (control group), where the regression rate was defined as the combined endpoint of cytology and histology. Success was regarded as either cytological regression, defined as an initial ASC-US, LSIL, ASC-H or HSIL disappeared or changed to lower level (e.g. LSIL to ASC-US etc.) after treatment OR histological regression; defined as an initial CIN 1 lesion disappeared after treatment, or as an initial CIN 2 lesion replaced by CIN 1 lesion or disappeared after treatment, respectively.

—

Secondary

Measure	Time frame
1. Cytological regression or remission according to Bethesda, in decreasing association with squamous precancerous disease: ASC-US, AGC, LSIL, ASC-H, HSIL, after 3 and 6 months of follow-up. Remission was defined as a complete recovery of cytological smear findings, whereas regression was defined as an improvement of cytological smear findings 2. Change in p16 (CINtec Plus test) after 3 and 6 months of follow-up 3. Overall clearance of the oncogenic HPV strains at 3 months. Clearance was defined as any hr-HPV+ (of those enumerated) at baseline that became hr-HPV- at 3 months	—

Measure

Time frame

1. Cytological regression or remission according to Bethesda, in decreasing association with squamous precancerous disease: ASC-US, AGC, LSIL, ASC-H, HSIL, after 3 and 6 months of follow-up. Remission was defined as a complete recovery of cytological smear findings, whereas regression was defined as an improvement of cytological smear findings 2. Change in p16 (CINtec Plus test) after 3 and 6 months of follow-up 3. Overall clearance of the oncogenic HPV strains at 3 months. Clearance was defined as any hr-HPV+ (of those enumerated) at baseline that became hr-HPV- at 3 months

—

Countries

Czech Republic

Contacts

Public ContactGertrude Markolin

gertrude.markolin@nutropia.at+43 (0)6476 805549

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026