- An innovative, strongly hydrating
mucoadhesive, clear gel for the local
treatment of vaginal atrophy
- Ultra-low concentration of estriol
(0.005% w/w estriol)
After 12 weeks of treatment, women receiving estriol gel (n=114) showed significant
improvements in the maturation value of vaginal epithelium (the primary endpoint – see Figure 4) and vaginal pH (see Figure 5) compared with those receiving placebo (n=53; p < 0.001 for both endpoints). There were also significant improvements in signs of vaginal atrophy such as fragility, dryness and pallor of the mucosa and flattening of folds.
secondary endpoints, statistical significance versus placebo was reached for vaginal dryness after 12 weeks of treatment, but not for dyspareunia, vaginal pruritus, burning or dysuria. Nevertheless, the mean global symptom score at week 12 was significantly lower in women treated with estriol than in those who received placebo (p=0.02).
In total 88.2% of estriol-treated patients reported improvement, or resolution, of vaginal dryness compared with 66.7% of patients who received placebo (p=0.001). The authors highlighted the hydrating properties of the gel vehicle, which was used (without the active ingredient) as the study placebo and could have contributed to the lack of significance achieved for some of the patient reported endpoints.
Treatment-related adverse events were similar in the two groups.
1. Blissel SmPC (Accessed February 2022)
2. Cano, A. et. al. 2012 ‘The therapeutic effect of a new ultra-low concentration estriol gel formulation (0.005% estriol vaginal gel) on symptoms and signs of postmenopausal vaginal atrophy: results from a pivotal phase Ⅲ study’, The North American Menopause Society, Volume 19, No.10, 1130-9
3. Caruso, S. et. al. 2016 ‘Quality of life and sexual function of naturally postmenopausal women on an ultralow-concentration estriol vaginal gel’, The North American Menopause Society. Volume 23, No.1, 47-54