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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT07024667
Eligibility Criteria:
Inclusion Criteria:
1. Female 45-75 years of age, at the time of enrolment.
2. Provided written informed consent.
3. Spontaneous induced menopause as defined by one of the followings:
* Amenorrhea of ≥12 months
* After bilateral oophorectomy
* FSH levels\>30 IU
4. One or more VVA related symptoms (i.e., itching, dryness, burning, pain, dyspareunia, or dysuria), after other possible causes of these complaints have been excluded.
5. Characteristic atrophic changes (see above) on gynaecological examination.
6. Normal Papanicolaou (PAP) smear test from the last 3-5 years: if needed and as indicated according to the Israeli guidelines.
7. Negative urine analysis test - urine stick.
8. Asymptomatic for bacterial or fungal vaginitis.
9. Vaginal canal, introitus and vestibule free of injuries and bleeding.
10. Able and willing to comply with the treatment/ follow-up schedule and requirements.
11. Normal general gynecological exam from the last year including US.
Exclusion Criteria:
1. Vaginal Health Index Score (VHIS) \< 5.
2. Active genital infection.
3. Vaginal bleeding which did not underwent evaluation.
4. Previous vulvar, vaginal or cervical dysplasia, within the last 2 years, or previous cancer.
5. Recurring urinary tract infection or recurring infection of genital herpes (≥ 3 episodes in the recent year).
6. Pelvic Organ prolapse (POP) \>II, according to the pelvic organ prolapse quantification system (POP-Q).
7. Serious systemic disease or any chronic condition that could interfere with study compliance.
8. Any local, systemic and/or chronic autoimmune infection.
9. Taken part in a clinical trial concerning VVA, within 30 days prior to the enrolment.
10. Allergy to lidocaine or tetracaine.
11. Genital skin disease that may interfere with the treatment (these subjects should be included/excluded according to the investigator's discretion).
12. Use of anticoagulants, within 5 days prior to enrolment.
13. Active positive HPV test.
14. Active positive HSV (Acute or actively present within the last 2 months).
15. Heavy smoker (\>1 pack of cigarettes a day)
16. Any disease or medication that may interfere with the wound healing/immune function.
17. Pregnancy / breast feeding.
18. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT07024667
Study Brief:
Protocol Section:
NCT07024667