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:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT04735718
Eligibility Criteria:
Inclusion Criteria:
* Adult females, aged 18 years to 65 years;
* Subjects presenting benign, ectopic, cervix lesions that were excised no later than 7 days before the Screening Visit, confirmed by colposcopy;
* Subjects presenting a normal cervical cytology report, e.g. Negative for Intraepithelial Lesions or Malignancy (NILM) or slightly modified to Atypical Squamous Cells of Undetermined Significance (ASC-US) in the last 6 months;
* Subjects willing to provide signed informed consent to clinical investigation participation.
Exclusion Criteria:
* Previous history of any malignancy, particularly those that are prone to metastases, including breast, melanoma, gestational trophoblastic disease, and high-grade malignancies of the gastrointestinal tract or lung;
* Subjects with undiagnosed abnormal genital bleeding;
* Subject with vulvar, vaginal or cervical cancer;
* Subjects presenting an abnormal cytology report, e.g. cervical intraepithelial neoplasia" (CIN) or "adenocarcinoma in situ" (AIS) in the last 6 months;
* Watery or foul discharge;
* Subjects with HIV or other immunodeficiency;
* Use of spermicides;
* Use of diaphragm;
* Concomitant topical or systemic anti-infective treatment;
* Unable to comply with visit procedures;
* Subjects included in other clinical investigations with similar objectives
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04735718
Study Brief:
Protocol Section:
NCT04735718