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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT02415868
Eligibility Criteria:
Inclusion Criteria:
1. Agree to study design (signed informed consent)
2. Post-menopausal women
3. Vaginal pH ≤4.5 or pH ≥5.5
4. At least 12 months of amenorrhea
5. Age ≥45 and ≤75
6. Currently in a mutually monogamous sexual relationship or not sexually active;
7. Sexually abstinent 48 hours prior to visit.
8. Willing and capable of following all study instructions; and
9. Good general health.
Exclusion Criteria:
1. Vaginal pH between \>4.5 and \<5.5
2. Use of topical estrogen containing product 1 week prior to enrollment
3. Use of vaginal lubricants, douches, or any products applied vaginally during the week prior to the first visit
4. Use of systemic estrogen therapy or products 6 months prior to inclusion
5. Use of a vaginal pessary during the week prior to the visit
6. Excessive alcohol usage (\>4 consumptions/day or \>20 consumptions/week)
7. Drug usage within past 2 years
8. A history or currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
9. A medical condition which might compromise immune system functions (such as cancer, leucopenia, HIV-positive, or organ transplant)
10. Antibiotics and/or anti-fungal medication use within the last four (4) weeks
11. Induced menopause due to surgical or medical interventions, such as bilateral oophorectomy, hysterectomy, chemotherapy or radiation treatment
12. Currently diagnosed with or being treated for a genital infection or urinary tract infection, subjects who had any vaginal infection one month prior to the screening will be excluded
13. Individuals with a sexually transmitted disease (self-reported or detected by the Principal Investigator)
14. At enrollment, have any social or medical condition, or psychiatric illness that, in the opinion of the Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
15. Participation in a clinical trial involving an investigational product/device within the past three months; subjects who are scheduled to participate in another clinical study concurrently.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT02415868
Study Brief:
Protocol Section:
NCT02415868