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

ObjectiveThe aim of the study was to confirm the superior efficacy of estriol containing pessaries compared to placebo in the treatment of vaginal atrophy.Study designIn 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 measuresPrimary efficacy endpoints included increase in VMI, decrease of the vaginal pH value and decrease in intensity of MBS after 12 weeks of treatment.ResultsThe 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.ConclusionsSuperiority 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.