New lower dose formulation of estradiol vaginal cream 0.003% relieves vulvovaginal atrophy.

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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.

Abstract 

More updates on vulvovaginal  syndrome of menopause:

FDA approves Prasterone (DHEA) for postmenopausal women experiencing dyspareunia

Applicator-free novel vaginal estradiol softgel capsule promising in relieving vaginal atrophy

NAMS updates  its position statement on HRT, clearing five critical areas of confusion

Endocrine Society issues guidelines for management of menopausal symptoms in breast cancer survivors