TABLE 1.

Baseline demographic and clinical characteristics of randomized participants

Demographic variablesa	Placebo (n = 271)	Estradiol (n = 277)
Age (y), mean ± SD	58.6 ± 6.1	58.7 ± 6.4
Not Hispanic/Latino ethnicity, n (%)	248 (91.5)	249 (89.9)
Race, n (%)b
White	248 (91.5)	255 (92.1)
Black	23 (8.5)	21 (7.6)
Asian	2 (0.7)	1 (0.4)
American Indian/Alaska Native	0	2 (0.7)
Native Hawaiian/Pacific Islander	1 (0.4)	0
Height (m), mean ± SD	1.63 ± 0.07	1.63 ± 0.07
Weight (kg), mean ± SD	70.9 ± 13.6	70.8 ± 15.0
BMI (kg/m2), mean ± SD	26.7 ± 5.3	26.7 ± 5.2

Clinical characteristics, mean ± SDc	Placebo (n = 233)	Estradiol (n = 239)
Dyspareuniad	2.7 ± 0.4	2.7 ± 0.5
Vaginal pHd	6.35 ± 0.66	6.37 ± 0.66
Percentage of vaginal cellsd
Superficial	0.2 ± 0.8	0.2 ± 0.7
Parabasal	50.6 ± 43.1	53.5 ± 42.0
Vaginal and/or vulvar irritation/itching	0.9 ± 0.9	1.0 ± 0.9
Dysuria	0.4 ± 0.7	0.4 ± 0.7
Vaginal dryness	2.3 ± 0.8	2.3 ± 0.7

Dyspareunia, vaginal/vulvar irritation/itching, dysuria, and vaginal dryness severity scores: 0 = none, 1 = mild, 2 = moderate, 3 = severe.

BMI, body mass index; mITT, modified intent-to-treat.

^aSafety population.

^bFive participants reported multiple races.

^cmITT population.

^dCoprimary assessments.