The effect of Deflagyn vaginal gel in premenopausal women with precancerous changes of the cervix

Cytokines in patients with HSIL, HPV positive >25 years old and <50 years old before and after Deflagyn vaginal gel compared to a control group with normal cytology (NILM)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87431813

Enrollment

115

Registered

2022-12-12

Start date

2022-12-24

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Local treatment of cervical precancerosis, prevention of cervical cancer Cancer

Interventions

Local treatment of precancerosis of the cervix with vaginal gel Deflagyn. The control group consists of patients with a normal PAP smear independent of the HPV test. In the study group (HSIL, HPV posi

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. HPV+, HSIL and control group 2. Squamo-cylindric junction visible in colposcopy 3. Acetic acid white lesion <50% of the ectocervix 4. Aged 25 years old and over to <50 years old (premenopausal)

Exclusion criteria

Exclusion criteria: 1. Cancer 2. Immunodeficiency (HIV) 3. Smoking 4. Pregnancy 5. Menometrorrhagia 6. Inflammatory and viral genital diseases (syphilis, gonorrhea, adnexitis)

Design outcomes

Primary

Measure	Time frame
Cytokine levels measured using multiplex immunoassay on analyzer Luminex 200 System before and after usage of Deflagyn	—

Secondary

Measure	Time frame
1. High-risk human papillomavirus (HR-HPV) positivity measured using PCR before and after treatment with Deflagyn 2. Cervical smear cytology measured using a liquid-based Pap-test before and after treatment with Deflagyn 3. Presence of cervical lesions diagnosed using colposcopy before and after treatment with Deflagyn 4. Lactobacillus in the cervical smear measured using scanning electron microscopy before and after treatment with Deflagyn 5. PH of cervical mucus measured using pH strips before and after treatment with Deflagyn 6. Assessment of cervical cancer risk measured using a questionnaire before treatment with Deflagyn 7. DNA methylation analysis measured using sequencing before and after treatment with Deflagyn	—

Measure

Time frame

1. High-risk human papillomavirus (HR-HPV) positivity measured using PCR before and after treatment with Deflagyn 2. Cervical smear cytology measured using a liquid-based Pap-test before and after treatment with Deflagyn 3. Presence of cervical lesions diagnosed using colposcopy before and after treatment with Deflagyn 4. Lactobacillus in the cervical smear measured using scanning electron microscopy before and after treatment with Deflagyn 5. PH of cervical mucus measured using pH strips before and after treatment with Deflagyn 6. Assessment of cervical cancer risk measured using a questionnaire before treatment with Deflagyn 7. DNA methylation analysis measured using sequencing before and after treatment with Deflagyn

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Countries

Uzbekistan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026