| Eligibility |
Inclusion Criteria:
- 1. Healthy biological female aged between 40 to 70 years 2. Is post-menopausal with a
AND b OR c:
1. No menses for at least 12 months
2. Follicle-stimulating hormone (FSH) level over 40mlU/mL
3. Has had a bilateral oophorectomy at least 12 months ago with no hormone
replacement 3. Is experiencing at least two self-reported symptoms of GSM, such
as
1. Vaginal irritation in the absence of infection
2. Chronic burning sensation
3. Chronic itching in the absence of infection
4. Recurring urinary tract infections (UTIs)
5. Vaginal dryness during sexual activity
6. Pain during sexual activity (dyspareunia) 4. Has been experiencing symptoms of
GSM for greater than 3 months 5. Is unable due to a medical contraindication or
unwilling to receive hormone-based vaginal therapy 6. Early menopause after
breast cancer 7. Normal and up to date pap smear, if applicable 8. Is sexually
active (i.e. intravaginal intercourse) or has the potential and desire to be
sexually active if symptoms of GSM improve 9. Can read, understand and sign
informed consent form 10. Has indicated willingness to participate in the study
by signing an informed consent form 11. Agrees to adhere to the treatment and
follow-up schedule and post treatment care instructions
Exclusion Criteria:
- 1. Undiagnosed abnormal genital bleeding 2. Has history of pelvic surgery or other
energy-based vaginal therapy within 12 months prior to enrollment 3. Previous use of
topical estrogen therapy within the last 6 months 4. Has used vaginal creams,
moisturizers, lubricants or homeopathic preparations, or received anticoagulants,
antiplatelet, thrombolytic, vitamin E or anti-inflammatory within 2 weeks of treatment
5. Has history of heart failure 6. Has equal to or greater than stage III prolapse,
according to pelvic organ prolapse quantification system (POP-Q) 7. Has an active
sexually transmitted infection (STI) 8. Has signs or symptoms of vulvitis/vaginitis 9.
Has signs or symptoms of acute urinary tract infection (UTI) 10. Has participated in
any clinical trial involving an investigational drug or procedure within past 30 days
11. The investigator feels that for any reason the subject is not eligible to
participate in the study
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