MsFLASH: Living a Healthy Menopause

The aims of this study are: 1) Conduct a 4-arm, double-blind, placebo-controlled randomized trial among postmenopausal women with vaginitis symptoms (moderate/severe vaginal dryness, burning, itching, pain or dyspareunia in the absence of infection) to compare the efficacy of: (a) the probiotic Lactin V, (b) ultra-low dose vaginal estrogen, (Vagifem 10 mcg), and (c) the combination of Lactin V + Vagifem to (d) matching placebos for relief of vaginitis symptoms after 8 weeks of treatment using the most bothersome symptom score as the primary trial outcome. 2) Using the cases recruited for the trial and a group of matched controls (women without symptoms of postmenopausal vaginitis), conduct a case-control study to determine whether patterns of vaginal bacterial colonization, such as pro-inflammatory anaerobic species, differ among women with and without symptoms of postmenopausal vaginitis.

0