Multinational multicenter open-label randomized controlled parallel trial comparing non-hormonal vaginal moisturizing cream to vaginal estriol cream in postmenopausal women with vaginal dryness

Introduction:

Multicenter open-label randomized controlled trial to test for non-inferiority of a non-hormonal vaginal moisturizing cream compared to vaginal estriol (E3) cream in postmenopausal women with vaginal dryness.

Materials and methods:

172 postmenopausal women with vaginal dryness were randomized to either 6-week treatment with non-hormonal vaginal moisturizing cream or E3-cream. Primary endpoint was to prove non-inferiority of the moisturizer based on a „total severity score” defined as sum score of single symptoms (vaginal dryness, itching, burning, pain). Secondary endpoints were symptom intensity of single symptoms, daily life impairment, vaginal health index (VHI), global judgement of efficacy and safety. Subjective and objective signs of vaginal atrophy were assessed at every visit (n = 3); symptoms were documented in a diary once weekly.

Results:

Non-inferiority of the moisturizing cream was confirmed regarding the difference of the mean „total severity score” at end of trial compared to baseline (PP; n = 80, treatment with moisturizing cream; n = 71, treatment with E3-cream; p = 0.0002). Subjective symptoms and daily life impairment improved by both treatments without significant intergroup difference. VHI also improved by both treatments. However, the difference between treatments was significant in favor of vaginal E3 (p < 0.0001). No serious adverse events. More adverse events related to vaginal E3 than to moisturizing cream. Positive global judgement of efficacy and tolerability was high (> 85%) for both treatments.

Conclusion:

A non-hormonal vaginal moisturizing cream significantly improves postmenopausal vaginal atrophy symptoms and may be used as first-line treatment for vaginal atrophy in accordance with the recommendations of the North American Menopause Society.