Low dose estriol pessaries for the treatment of vaginal atrophy: A double-blind placebo-controlled trial investigating the efficacy of pessaries containing 0.2 mg and 0.03 mg estriol

Objective: The aim of the study was to confirm the superior efficacy of estriol containing pessaries compared to placebo in the treatment of vaginal atrophy. Study design: In a prospective, multicenter, randomized, placebo-controlled, double-blind study, 436 postmenopausal women with vaginal atrophy (vaginal maturation index, VMI < 40%; vaginal pH > 5; most bothersome symptom, MBS >= 65 on visual analogue scale, VAS) were treated with pessaries containing either 0.2 mg estriol (N=142) or 0.03 mg estriol (N=147) or with a matching placebo (N=147) for 12 weeks. Main outcome measures: Primary efficacy endpoints included increase in VMI, decrease of the vaginal pH value and decrease in intensity of MBS after 12 weeks of treatment. Results: The increase in VMI was significantly greater under 0.2 mg estriol and 0.03 mg estriol (46.3 +/- 17.0 and 38.4 +/- 19.4, respectively) compared to placebo (23.9 +/- 21.5; p values <0.001), vaginal pH decreased significantly more (-1.6 +/- 0.8 and -1.4 +/- 0.9, respectively) compared to placebo (-0.6 +/- 0.8; p values < 0.001) and MBS intensity (VAS) declined significantly more (-52.2 +/- 23.7 and -47.1 +/- 23.4, respectively) compared to placebo (-31.8 +/- 26.3; p values <0.001). Adverse events were rare and occurred at similar rates in all three groups. Conclusions: Superiority of estriol containing pessaries over placebo was shown in the local treatment of vaginal atrophy. Even a very low dose of 0.03 mg estriol proved sufficient for local treatment of vaginal atrophy with excellent tolerability. (C) 2012 Elsevier Ireland Ltd. All rights reserved.