Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT04624568
Eligibility Criteria:
Inclusion Criteria:
* Women aged 25 years old or older.
* With histologically-confirmed cervical intraepithelial lesion 1 only, proven by colposcopy biopsy, done in the most suspiscious area.
* With complete colposcopy, performed less than 3 months prior the inclusion
* With confirmed ASC-US or LSIL cervical-cytology, performed less than 6 months prior the colposcopy.
Exclusion Criteria:
* Women under guardianship or curatorship
* Women under the protection of justice
* Women not affiliated with a social security system
* Pregnant woman (as vaginal gel has not been evaluated in pregnant women) Urinary dosing of BHCG will be performed on the day of inclusion for all women under 55 years of age and effective contraception is recommended during the study for all non-menopausal women.
* Immunodepressed women (HIV, immunosuppressive treatments ...)
* Woman using vaginal contraceptives (ring, spermicides, cervical cap; because of risk of interaction) NB: Papilocare is compatible with the use of condoms and intrauterine devices.
* Known allergy to one of the components
* Patients with low-grade histology with HSIL - ASC-H - AGC smear will not be included. The cyto-colposcopic discordance suggests a high-grade lesion that would not have been biopsied at colposcopy.
* Patients undergoing laser or conization treatment according to the recommendations of INCa 2016 will not be included; namely: persistence of CIN 1 for more than 24 months on at least 2 different colposcopies; high-grade squamous intraepithelial histological lesions; adenocarcinoma in situ.
* Participation in another interventional study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Study:
NCT04624568
Study Brief:
Protocol Section:
NCT04624568