menopausal (no menses in 12 months) within 2 years of last menstrual period or perimenopausal in the late menopausal transition, defined as an interval of amenorrhea greater than or equal to 60 days
have symptoms of the genitourinary syndrome of menopause (GSM) which developed within the prior 2 years. Symptoms of GSM include vaginal symptoms including dryness, soreness, itching, irritation and dyspareunia and/or urinary symptoms including urgency, frequency and recurrent urinary tract infections (UTIs)
You may not be if
Unexplained or unevaluated abnormal genital bleeding
Current or suspected pregnancy
Desired pregnancy
If less than 55 years old, have had a hysterectomy and have at least one ovary (as menopause cannot be determined in this case by amenorrhea alone)
Pelvic or vaginal surgery in the prior 60 days
Used systemic reproductive hormones in the last 2 months
Used antibiotics in the last 30 days
Used immunosuppressive medications in the prior 60 days including biologics, chemotherapeutics or post transplant immunosuppressive medications
Used any vaginal or vulvar preparations in the last month
Current active vaginal infection diagnosed at study entry
Any serious disease or condition that may interfere with study compliance
Current or previous history of breast cancer or estrogen dependent cancer (e.g., ovarian, endometrial)
Current or previous history of deep vein thrombosis or pulmonary embolism
Current or previous history of myocardial infarction or stroke
Known clotting disorder including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations
Known severe liver disease including cirrhosis or active Hepatitis B
Known allergic reaction to Vagifem (estradiol vaginal tablet) or Replens
