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Low dose estradiol vaginal cream 0.003% helps in relieving symptoms of
vulvovaginal atrophy (VVA) in postmenopausal women says the results of phase 3
trial published September 18, in Journal Menopause.
This randomized, double blind, placebo control trial recruited a total of
550 sexually active postmenopausal women who were bothered by moderate to
severe dyspareunia. The average age was 58 years. These women also had vaginal
pH > 5.0 and cytology revealed only 5% superficial cells.
The women were randomized to receive either placebo or the 0.003%
estradiol cream applied daily for two weeks, followed by three applications per
week for 10 weeks. The women were assessed in terms of relief from dyspareunia,
improvement in superficial cell cytology and decrease in pH.
After completing the treatment, women receiving estradiol cream reduced dyspareunia
by 1.5 points vs 1.2 points in women with placebo. Estradiol also improved
superficial cells by 10.1% vs 1.4% in placebo, vaginal pH reduced by 1.36
versus 0.53 for placebo.
Estradiol cream also relieved irritation, itching, dryness more effectively
as compared to placebo (P < 0.01).
Mycotic fungal infections were significantly more common in estradiol group.
“Lower-dose estradiol vaginal cream (0.003%) dosed three applications/week
is an effective and well-tolerated treatment for VVA-related dyspareunia,” the
authors concluded.
The study was sponsored by Allergan, which is developing the new low dose
0.003% cream, the company’s other cream Estrace, which have 0.01%
estradiol is already approved by the U.S. Food and Drug Administration for
treating postmenopausal VVA.
