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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT04766957
Eligibility Criteria:
Inclusion Criteria:
* Women who attend medical centers, either for a visit related to vulvovaginal atrophy (VVA) or for any other reason for consultation, with symptoms of VVA (dryness and / or dyspareunia) of moderate or severe intensity (score 2-3 on the Likert scale).
* Women between the ages of 40 and 65, inclusive, in the peri- or postmenopausal period.
* Women are able to understand and sign the informed consent after the nature of the study has been fully explained to them.
Exclusion Criteria:
* Pregnant or immediate postpartum patients (up to 40 days).
* Formal contraindication for the use of the product, such as hypersensitivity to any of the components of the study treatment.
* Use of any other experimental drug or device during the 30 days prior to screening.
* Use of topical antibiotics or antifungals applied vaginally in the two weeks prior to the initial visit.
* Use of contraceptives for vaginal application.
* Decompensated chronic diseases (diabetes, epilepsy, high blood pressure, etc.)
* Undiagnosed abnormal genital bleeding or presence of vaginal lesion.
* Active genitourinary infections at the time of inclusion or in the 15 days prior to inclusion in the study.
* Impossibility, at the discretion of the researcher, to comply with the requirements of the study, either due to follow-up problems, or due to their psychophysical characteristics.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT04766957
Study Brief:
Protocol Section:
NCT04766957