Association of Vaginal Estradiol Tablet With Serum Estrogen Levels in Women Who Are Postmenopausal: Secondary Analysis of a Randomized Clinical Trial

Serge Rozenberg

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Serge Rozenberg

Caroline M Mitchell et al compare serum estrogen concentrations with the use of vaginal

estrogen, 10 μg, tablet vs placebo in women who are postmenopausal. (JAMA Netw Open.

2022 Nov 1;5(11):e2241743. doi: 10.1001/jamanetworkopen.2022.41743.) in a secondary,

post hoc analysis of data from a randomized clinical trial of treatment for moderate to

severe genitourinary syndrome in women who are postmenopausal. In this post hoc

analysis, baseline and week 12 serum estradiol, estrone, and sex hormone-binding globulin

(SHBG) concentrations were measured by a chemiluminescent assay. A total of 174 women,

mean (SD) age 61 (4) years, were included. Those in the estrogen group (n = 88) were more

likely to have higher geometric mean (SD) week 12 serum estradiol concentrations (4.3 [2.2

pg/mL]) than those in the placebo group (n = 86) (3.5 [2.1] pg/mL) (P = .01). Adjusted for

pretreatment hormone concentrations, age, clinical site, and body mass index, assignment

to the estrogen vs placebo treatment group was significantly associated with higher week

12 estradiol concentrations (23.8% difference; 95% CI, 6.9%-43.3%). Most (121 of 174

[69.5%]) participants had enrollment serum estradiol concentrations higher than 2.7 pg/mL.

Of women starting treatment at estradiol levels lower than or equal to 2.7 pg/mL, 38.1% (8

of 21) in the estrogen group and 34.4% (11 of 32) in the placebo group had estradiol

concentrations higher than 2.7 pg/mL after 12 weeks of study participation (P = .78).

Treatment assignment was not associated with week 12 estrone or SHBG concentrations.

Conclusions and relevance: In this secondary analysis of a randomized clinical trial, a

significant, although small, increase in serum estradiol levels was noted after 12 weeks of

vaginal estrogen administration. The clinical relevance of this small increase is uncertain.

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