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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT05156502
Eligibility Criteria:
Inclusion Criteria:
* menopausal women aged between 40 and 70 years old (defined as Absence of menstruation for 12 consecutive months).
* women affected by Genitourinary syndrome of menopause (GSM) with Vaginal dryness, burning/pain, dyspareunia, dysuria.
* women not treated with Replacement therapy with estrogen and progestogen (HT) or estrogen alone (ET) or selective estrogen receptor modulators (SERMS) in the last 3 months
Exclusion Criteria:
* hypersensitivity to laser
* clinically significant findings on physical examination
* any chronic medical condition or psychologic disorder that per opinion of the Principal Investigator would make the patient ineligible for the study
* vulvo-vestibular lesion not related with GSM
* active vaginal or vulvar infections (e.g., herpes, candida, STIs)
* prolapse beyond the hymen
* subject has a history of scarring alteration (ie, keloid formation)
* unknown past or active history of vaginal bleeding disorders
* any condition or behavior indicating to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT05156502
Study Brief:
Protocol Section:
NCT05156502