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 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT06142695
Eligibility Criteria:
Inclusion Criteria:
* Age \<75 years, menopause (naturally, pharmacologically or surgically induced, at least 12 months)
* Negative Papanicolaou test (PAP) performed within 12 months before enrolment. and one of the following:
* Presence of vulvovaginal atrophy \[vaginal health index (VHI) \< 15\]
* Initial Urinary Incontinence based on patient history = 1 (according to the "Stamey incontinence score of Stress Urinary Incontinence" - min. 0 = no incontinence, max. 3 = severe incontinence)
* Standardized stress provocation test
Exclusion Criteria:
* Age \>45 years
* The presence of vaginal lesions (active or in the previous 30 days).
* genitourinary tract infection.
* abnormal uterine bleeding.
* use of hormone replacement therapy up to 6 months before enrolment.
* history of photosensitivity disorder or use of photosensitizing drugs.
* genitals prolapse (grade II - III according to the Pelvic Organ Prolapse Quantification)
* a serious or chronic condition that could interfere with study compliance.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT06142695
Study Brief:
Protocol Section:
NCT06142695