TABLE 1.
Parameter | Vaginal E2 softgel (N = 24) | Placebo (N = 24) |
Age, y | 62.4 ± 5.7 | 62.6 ± 7.3 |
BMI, kg/m2 | 26.4 ± 3.9 | 27.4 ± 3.4 |
Estradiol, pg/mLa | 8.38 ± 9.54 | 6.96 ± 7.56 |
Parabasal cells, % | 62.5 ± 40.1 | 64.6 ± 38.8 |
Superficial cells, % | 1.7 ± 2.4 | 0.2 ± 1.0 |
Intermediate cells, % | 35.8 ± 38.3 | 35.2 ± 38.4 |
pH | 6.00 | 6.13 |
MBS (mean severity scoreb) | 2.52 | 2.58 |
VVA symptoms (mean severity scoreb) | ||
Vaginal dryness | 2.292 | 2.375 |
Vaginal and/or vulvar irritation/itching | 0.875 | 1.333 |
Pain, burning, or stinging when urinating | 0.583 | 0.625 |
Sexually active womenc | ||
Vaginal pain with sexual activity (mean severity score) | 2.083 | 2.333 |
Vaginal bleeding with sexual activity, % | 25 | 33.33 |
Data are presented as the mean ± SD, except where noted.
BMI, body mass index.
aValues below 10 pg/mL were set to 0.0.
bSubjectively assessed as 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
cn = 12 women for each study arm sexually active at baseline.