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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07419035
Eligibility Criteria:
Inclusion Criteria:
* Women aged 40 to 65 years
* Postmenopausal status
* Presence of at least one symptom of genitourinary syndrome of menopause (e.g., vaginal dryness, irritation, pruritus, urinary symptoms, or dyspareunia)
* Sexual activity at least once per month
* Ability to understand and complete study questionnaires
* Provision of written informed consent
Exclusion Criteria:
* Active vaginal infection
* Neurological, neoplastic, or sexually transmitted diseases
* Diagnosis of vulvodynia or vaginismus
* Pelvic organ prolapse stage II or higher
* Pelviperineal hypoesthesia
* Presence of pacemaker or other electronic implantable devices
* Use of estrogen hormonal therapy within the previous 3 months
* History of pelvic radiotherapy
* Pelvic surgery within the previous 6 months
* Active anticoagulant therapy
* Previous vaginal laser or ablative vaginal rejuvenation procedures within the previous 6 months
* Cognitive impairment preventing completion of questionnaires
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT07419035
Study Brief:
Protocol Section:
NCT07419035