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 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT05571527
Eligibility Criteria:
Inclusion Criteria:
* Women with menopause
* Patients with symptoms of genitourinary syndrome of menopause
Exclusion Criteria:
* Genitourinary bleeding or infection without a definitive diagnosis
* Coagulopathy
* Allergy to medication or therapy related to the treatment
* Chronic disease that might influence the outcome
* Using medication that might influence the outcome in 30 days
* Using hormone or steroid within 8 weeks
* Personal history of vulvovaginal conditions such as lichen sclerosis, lichen planus, vulvovaginal condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, history of cervical or other gynecologic cancer, radical pelvic surgery, acute or recurrent urinary tract infection, genital infection, history of vaginal or pelvic radiation
* Chronic pelvic pain, current pelvic tension myalgia/muscle hypertonicity
* Pelvic organ prolapse greater than stage II
* Pelvic surgery within 6 months
* Known allergy to lidocaine or prilocaine
* Use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of therapy
* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT05571527
Study Brief:
Protocol Section:
NCT05571527