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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT04021966
Eligibility Criteria:
Inclusion Criteria:
Healthy women with menopausal status (\>1 year amenorrhea) AND with moderate to severe symptoms of VVA as measured by the MBS score ≥2.
Exclusion Criteria:
* Acute or recurrent urogenital infections
* Prolapse ≥ grade 3 according to the Pelvic Organ Prolapse Quantification System
* Hormonal replacement therapy within the last 6 months before study entry
* Use of local estrogens, moisturizers, lubricants or homeopathic preparations within the last 3 months
* Pelvic floor physiotherapy for pelvic floor disorders within the last 3 months
* Any condition that could interfere with study compliance
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT04021966
Study Brief:
Protocol Section:
NCT04021966