Local Estrogen Therapy for Vaginal Atrophy Can Start Before or After Age 60

By Marilynn Larkin

October 22, 2020

NEW YORK (Reuters Health) - Treatment with low-dose local estrogen therapy (ET) to improve symptoms of vaginal atrophy may start before or after age 60, according to a post-hoc analysis of a randomized, placebo-controlled trial in the US and Canada.

"A major aim for us was to draw attention to genitourinary syndrome of menopause (GSM), of which, as noted, vulvovaginal atrophy (VVA) is a major component," Dr. Christine Derzko of the University of Toronto and St. Michael's Hospital told Reuters Health by email. "Too many affected women ignore the symptoms they are experiencing or at the very least fail to seek medical attention for them, unaware that an effective treatment is available. They have come to believe that this is but a consequence of aging and that they should simply put up with it."

"Vaginal estrogen works well in both the older and the younger age group (under or over age 60) when measured both subjectively and objectively," she said. "This is probably the most important...message for both healthcare providers and their patients."

"It takes a little longer to achieve the objective result in the older women, which is something that (prescribers) need to appreciate - treatment needs to be continued," she noted. "Similarly, patients need to know that the data show that if they persist with treatment, they will be successful in achieving their goal and satisfying their need. If they stop treatment and symptoms recur (treatment) will need to be restarted and continued, in the absence of contraindications."

As reported in Menopause, Dr. Derzko and colleagues did a post-hoc analysis of data from a double-blind, randomized, placebo-controlled trial (NCT00108849), which treated 205 postmenopausal women ages 45 and over with 10 mcg vaginal ET for one year.

Women younger or older than 60 at treatment start were evaluated according to vaginal maturation index (VMI; assessed by vaginal cytology samples), vaginal pH and "most bothersome" symptom (both graded on four-point scales).

Vaginal ET improved the VMI for all cell layers, as well as vaginal pH and symptom scores for both age groups.

However, cytological profiles were significantly different in the two groups. At baseline, the proportion of parabasal cells was lower in younger women (37.8% vs. 52.3%), whereas younger women had a higher proportion of intermediate cells (58.9% vs. 44.5%). By contrast, the baseline proportions of superficial cells were similar between the groups (3.3% and 3.2%.

At week 52, the proportions of parabasal cells were reduced in both younger and older women, to 4.6% and 11.2%, respectively. Similarly, the proportions of intermediate and superficial cells were increased in both groups to 79.2% and 72.9% for intermediate cells, and 16.2% and 15.9% for superficial cells, respectively.

An analysis of covariance showed significant differences in VMI changes from baseline to week 52 between age groups for parabasal and intermediate cells, with an estimated effect of -3.7 and 5.8 for parabasal and intermediate cells, respectively, indicating reduced cellular responsiveness to treatment among older women.

Further, the treatment effect on vaginal pH was less for older women, with a between-group difference of -0.19.

The authors note that vaginal ET can be initiated at any age and will improve symptoms. "The stronger response observed in younger women supports current clinical recommendations to start treatment early. Continued treatment may be important to avoid recurrence of vaginal atrophy," they conclude.

Dr. Derzko added that clinicians need to provide an environment in which women feel safe and comfortable talking about their vaginal atrophy or genitourinary syndrome of menopause (GSM).

Dr. Harvey Winkler, System Chief, Fellowship in Female Pelvic Medicine and Reconstructive Surgery: Urogynecology at Northwell Health in New York told Reuters Health by email, "At treatment start, women aged <60 years had a more robust response than women 60 years of age or older. However, as women age and enter the older age group, we do not know if this benefit will continue. Longer follow-up can show whether the more robust benefits do or not decrease over time."

Like Dr. Derzko, he concluded, "Many women unnecessarily suffer from vaginal atrophy and GSM, and vaginal estrogen can successfully and safely treat these symptoms."

The study was funded by Novo Nordisk. Dr. Derzko and a coauthor have received funding from the company, although not for this study; one coauthor is an employee.

SOURCE: https://bit.ly/35jxNvP Menopause, online October 5, 2020.