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 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT06503003
Eligibility Criteria:
Inclusion Criteria:
* Post-menopausal women aged 45-73 years.
* Sexually active.
* Experiencing physiological amenorrhea for more than 12 months.
* Exhibiting at least one symptom of Genitourinary Syndrome of Menopause (GSM).
* Not using lubricants or hormonal therapy in the previous 6 months.
* Able to provide written informed consent.
Exclusion Criteria:
* Untreated uterine or vulvovaginal cancers.
* Pacemaker or other implanted electrode carriers.
* Severe multi-organ or neurological diseases.
* Active sexually transmitted infections.
* Moderate to severe uterine prolapse.
* Active urinary tract infections.
* Acute or chronic dermatological conditions in the vulvar or vaginal area.
* Active genital herpes.
* Active high-risk Human Papillomavirus (HPV).
* Ischemic tissues, unhealed wounds, sores, or undiagnosed mucosal or epithelial alterations.
* Recent unhealed invasive or ablative surgeries.
* Bleeding disorders or anticoagulant therapy.
* Immunodeficiencies.
* Uncontrolled diabetes.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
73 Years
Study:
NCT06503003
Study Brief:
Protocol Section:
NCT06503003