Clinical Research Directory

Inclusion Criteria: * female * at least 40 years old * 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) Exclusion Criteria: * 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