Lower-dose estradiol cream efficacious in vulvovaginal atrophy

By Reuters Staff

NEW YORK (Reuters Health) – Low-dose estradiol cream can reduce symptoms of vulvovaginal atrophy (VVA) in postmenopausal women, according to a phase 3 trial published in Menopause.

“Estradiol vaginal cream was efficacious compared with placebo in reducing the severity of dyspareunia, decreasing vaginal pH, and improving the percentage of vaginal smear superficial cells while reducing parabasal cells from baseline to final assessment,” Dr. James H. Liu of University Hospitals Cleveland Medical Center and colleagues write in their September 18 online report.

Allergan, which is developing the 0.003% estradiol vaginal cream, funded the study. The company also makes a 0.01% estradiol vaginal cream, Estrace, approved by the U.S. Food and Drug Administration for treating postmenopausal VVA.

The new study included 550 sexually active postmenopausal women (mean age, 58) who reported dyspareunia as their most bothersome VVA symptom. They were randomly assigned to placebo or the 0.003% estradiol cream applied daily for two weeks, followed by three applications per week for 10 weeks.

Dyspareunia was reduced by 1.5 points, versus 1.2 points with placebo. Vaginal pH declined by 1.36 versus 0.53 for placebo. Cytology also improved, with a 10.1% increase in superficial cells with estradiol and a 1.4% increase with placebo, and reductions of 48.5% and 14.6%, respectively, in parabasal cells.

About half of each group reported one or more treatment-emergent adverse events, with vulvovaginal mycotic infections the most commonly reported in the active treatment group (6.9% with estradiol vs. 3.3% with placebo).

This is “not unexpected,” the researchers note, and could be due to the decrease in pH with hormone treatment. Changes in the vaginal microbiome and direct effects on candida bacteria could also be factors, they add.

More than half of women report VVA symptoms after menopause, but just 56% say they have talked about the issue with a health care provider, Dr. Liu and his team note. While symptoms such as hot flashes and night sweats can ease over time, they add, VVA symptoms do not improve and can worsen without treatment.

“Lower-dose estradiol vaginal cream may provide another treatment option for women who are concerned over the safety of systemic estrogen exposure or for those (for) whom greater doses of estrogen may be contraindicated,” they conclude.

Dr. Liu was not available for an interview by press time.

SOURCE: http://bit.ly/2xvw0Vl

Menopause 2017.

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