VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women

Exclusion Criteria

• •1. History of breast, uterine or ovarian cancer or melanoma.
• •2. Abnormal mammogram or breast examination within the last 9 months suggestive of cancer.
• •3. Abnormal Pap smear or pelvic examination within the last 9 months suggestive of cancer.
• •4. Any uterine or vaginal bleeding within the six months prior to enrollment (except following the screening Pap smear).
• •5. Double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound.
• •6. Pregnant or lactating.
• •7. Use of any vaginal moisturizer (Replens, KY Silk-E, Astroglide Silken Secret, Senselle) within 30 days of screening.
• •8. Use of any oral, transdermal, vaginal, or systemic estrogen or estrogen/progestin product within 30 days of screening.
• •9. Use of raloxifene, tamoxifen or aromatase inhibitors within 12 weeks of screening.
• •10. Current urinary tract infection (dipstick urinalysis positive for leukocyte estrace, nitrates or blood)
• •11. History of cardiovascular disease.
• •12. History of venous thromboembolic disease.
• •13. Use of another investigational agent within 12 weeks of screening.
• •14. Any medical or psychiatric condition that, in the investigator's opinion, would preclude the participant from completing questionnaires or measures, adhering to the protocol or completing the trial, including limited English literacy, severe illness, plans to move, substance abuse, significant psychiatric problems, or dementia.
• •15. No access to a telephone