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

Abstract

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 0.2mg estriol (N=142) or 0.03mg 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 0.2mg estriol and 0.03mg 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 0.03mg estriol proved sufficient for local treatment of vaginal atrophy with excellent tolerability.

• Authors: Henrik Griesser, Stefan Skonietzki, Thomas Fischer, Karin Fielder, Marija Suesskind
• Journal: Maturitas (Maturitas) Vol. 71 Issue 4 Pg. 360-8 (Apr 2012) ISSN: 1873-4111 [Electronic] Ireland
• PMID: 22285095 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Chemical References

• Estriol

Topics

• Administration, Intravaginal
• Adult
• Aged
• Aged, 80 and over
• Atrophy
• Double-Blind Method
• Estriol (administration & dosage, pharmacology, therapeutic use)
• Female
• Humans
• Hydrogen-Ion Concentration
• Middle Aged
• Pessaries
• Postmenopause
• Prospective Studies
• Treatment Outcome
• Vaginal Diseases (complications, drug therapy, pathology)