Vaginal pills increase plasma estradiol levels in postmenopausal women | Tech Reddy

According to a post hoc analysis, postmenopausal women with moderate to severe genitourinary syndrome experienced a small but significant increase in plasma estradiol after 12 weeks of vaginal estradiol tablets. JAMA Network Open.

The researchers cautioned that the clinical significance of this increase is limited.

“Current ACOG guidance suggests that low-dose vaginal estrogen is a reasonable treatment option [for genitourinary symptoms] For women with estrogen-dependent breast cancer” Caroline M. Mitchell, MD, MPH, Written by Director of the Vulvovaginal Disorders Program at Massachusetts General Hospital in Boston and colleagues.

However, according to the study, there is no information about the risk of breast cancer with the use of vaginal estrogen preparations, and there is little information about safe estradiol concentrations for postmenopausal women.

Mitchell and colleagues conducted a secondary analysis of the MsFLASH Vaginal Health Trial, a randomized, double-blind, placebo-controlled, 12-week clinical trial conducted from April 11, 2016, to April 23, 2017, at Kaiser Permanente, Washington. Seattle Research Institute and University of Minnesota, Minneapolis.

A secondary analysis included data from 174 postmenopausal women aged 45 to 70 years with moderate to severe genitourinary syndrome, of whom 88 were assigned vaginal estradiol tablets 10 mcg plus placebo gel and 86 were assigned placebo tablets and gel. Participants completed questionnaires on the severity of bothersome vaginal symptoms, sexual activity, quality of life during menopause, depression, anxiety, and insomnia, and provided blood samples at enrollment and at 12 weeks.

Women in the estradiol group had higher estradiol levels at week 12 compared with the placebo group (geometric mean, 4.3 pg/mL vs. 3.5 pg/mL; P = .01). Adjusting for baseline hormone concentrations, age, location, and BMI, estradiol pills versus placebo had significantly higher estradiol levels at week 12 (difference, 23.8%; 95% CI, 6.9%-43.3%).

“To better assess the potential clinical relevance of this association, we compared the characteristics of women with 12-week estradiol concentrations below or equal to (2.7 pg/ml) breast cancer,” wrote Mitchell and colleagues.

Most women (69.5%) had estradiol levels greater than 2.7 pg/ml at baseline, with 21 women in the estradiol group and 32 women in the placebo group having concentrations at or below the threshold. Of these, eight (38.1%) women in the estradiol group and 11 (34.4%) women in the placebo group had estradiol levels greater than 2.7 pg/mL at week 12.

Notably, there was no correlation between the prescription of estradiol pills and levels of estrone and sex hormone-binding globulin.

“A very large randomized clinical trial is needed to definitively answer the question of whether low-dose vaginal estrogen preparations are safe,” the researchers wrote.