New study reassures postmenopausal women about safety of vaginal estrogen.

Postmenopausal women using vaginal estrogen are not at increased risk of cardiovascular disease and cancer reports the result of study published August 14, 2017 in Menopause.

This is another important study conducted using data from Women's Health Initiative(WHI) observational study which tracked the medical history and health habits of 93,676 women nationwide for 8-12 years. The current study recruited 45,663 women between 50-79 years of age, across 40 US clinical centers. These women did not use systematic estrogen and underwent a median follow-up of 7.2 years.

Results of this prospective observational cohort study showed that in women with intact uterus and using vaginal estrogen, the risk of cardiovascular event, pulmonary embolism, stroke, invasive breast cancer, endometrial and colorectal cancer does not exceed the risk faced by non-hormone users.

Women using vaginal estrogen had 32% lower risk of global index event (GIE), defined as time to first occurrence of coronary heart disease (CHD), invasive breast cancer, stroke, pulmonary embolism, hip fracture, colorectal cancer, endometrial cancer, or death from any cause as compared to non-users (GIE adjusted hazard ratio 0.68, 95% confidence interval 0.55-0.86).

Surprisingly, in Hysterectomized women the composite risk of GIE or individual event did not differ much among users and non-users (GIE adjusted hazard ratio 0.94, 95% confidence interval 0.70-1.26).

Based on the results of this trial, US FDA is considering a proposal to revise the warning labels on low dose estrogen packaging to incorporate the safety profile of vaginal estrogen.

Current labels were approved before any evidence was put forth about safety of vaginal estrogen and it may discourage patients from using topical estrogen which are safe and highly effective in treatment of genitourinary symptoms of menopause. 

Different formulations like topical creams, an intravaginal insert, and an intravaginal ring have the same safety and efficacy.

JoAnn Pinkerton, MD, executive director, North American Menopause Society (NAMS), said in a  position statement released by North American Menopause Society on August 17, “These findings should reassure women and their healthcare providers that low-dose vaginal estrogen, which keeps blood levels within the normal postmenopausal range, is effective and safe for postmenopausal women who need relief from only vaginal symptoms,” says Dr. JoAnn Pinkerton, NAMS executive director. “The boxed warnings about the risk of heart disease, stroke, blood clots, and cancer do not apply to these low-dose vaginal therapies. Instead, women who experience bleeding or those with breast cancer should include their healthcare providers and oncologists in deciding about this option.”

Access the Abstract, NAMS position statement.