Clinical trial · Interventional
Safety and Efficacy Study of Antiviral Local Application to Treat High Grade Cervical Intraepithelial Lesions (CIN2/3)
A Randomized, Double-blind, Multi-centre, Placebo Controlled Phase II Clinical Study to Evaluate the Efficacy, Tolerance and Safety of an Aqueous Gel Containing an Antiviral, Directly Applied on the Cervix Exhibiting High Grade Intraepithelial Lesion.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this phase-II study is to evaluate the efficacy and safety of an aqueous gel containing an antiviral, administered directly on cervix exhibiting high grade squamous or glandular intraepithelial lesion (CIN 2 and 3) in comparison with a placebo treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervix Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Uterine Cervical Neoplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group
- interventionNames
- Drug: C1
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- interventionNames
- Drug: C1
Primary outcomes (3)
- measure
- Efficacy at week 12: change of histological and cytological parameters (success or not)
- timeFrame
- 12 weeks
- description
- Efficacy will be measured by histological and cytological criteria at week 12 (disappearance of CIN 2+) in correlation with viral status (positive or negative) before and after treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged between 18 and 50 years old * Informed consent signed * Cervical lesion classified CIN 2 or 3, on a biopsy made during the 60 days before inclusion * No sexual activity, or proved sterility, or use of effective mechanical, hormonal or intrauterine contraception during 30 days following inclusion (except vaginal ring Nuvaring, diaphragm and spermicide) Exclusion Criteria: * Invasive or microinvasive cervical neoplasia * Pregnancy or breast feeding * Subtotal hysterectomy * Current renal impairment * Current immune disorder including serology HIV + * Current use of drugs interfering with renal function * Current use of oncologic treatment * Current use of immune treatment * Current use of anti-viral treatment * Current vaginal application of drugs or cosmetics * Prior treatment with the antiviral on the cervix * Local or general condition incompatible with the experimental treatment in the opinion of the principal investigator * Current or recent participation to another experimental study during the last 3 months before the screening visit
References
Publications (0)
Data not yet available