Table 1.
Demographic, laboratory and symptom characteristics at enrollment.
| MBS Improved (n = 21) |
MBS did not improve (n = 9) |
p valuea | |
|---|---|---|---|
| Age (years, mean ± SD) | 53 ± 4 | 54 ± 4 | 0.82 |
| BMI (kg/m2, mean ± SD) | 30 ± 7 | 27 ± 4 | 0.31 |
| Ethnicity | 0.77 | ||
| White | 9 (43%) | 5 (56%) | |
| African American | 10 (48%) | 3 (33%) | |
| Hispanic | 1 (5%) | 1 (11%) | |
| Other | 1 (5%) | 0 | |
| Study arm | 0.22 | ||
| Placebo | 7 (33%) | 6 (67%) | |
| Venlafaxine | 7 (33%) | 2 (22%) | |
| Estradiol | 7 (33%) | 1 (11%) | |
| Menopausal status | 0.84 | ||
| LMP < 1 year | 4 (19%) | 2 (22%) | |
| LMP > 1 year | 17 (81%) | 7 (78%) | |
| Female Sexual Function Index (median, IQR) | 21 (12, 27) | 20 (18, 23) | 0.82 |
| PHQ-9 (median, IQR) | 2 (0, 4) | 6 (3, 10) | 0.008 |
| GAD-7 (median, IQR) | 2 (0, 3) | 5 (2, 10) | 0.02 |
|
| |||
| Vasomotor symptoms | |||
|
| |||
| Hot flashes/day at week 0 (median, IQR) | 8 (6, 9) | 6 (5, 11) | 0.39 |
| >50% decrease in hot flashes/day at week 8 | 7 (33%) | 3 (33%) | 1.0 |
|
| |||
| Baseline laboratory values | |||
|
| |||
| Vaginal glycogen (pg/mL, median, IQR)b | 5.3 (2.7, 8.3) | 7.1 (4.3, 166) | 0.12 |
| Estradiol (pg/mL, median, IQR)c | |||
| Total | 22 (4, 30) | 14 (0.5, 20) | 0.31 |
| Unconjugated | 3 (0.5, 7) | 5 (0.5, 6) | 0.99 |
| Estrone (pg/mL, median, IQR)c | |||
| Total | 195 (146, 314) | 173 (122, 229) | 0.27 |
| Unconjugated | 26 (22, 40) | 27 (12, 35) | 0.61 |
| Lactobacillus-dominant vaginal microbiota | 12 (57%) | 2 (22%) | 0.08 |
| L. crispatus (+ qPCR) | 10 (48%) | 2 (22%) | 0.11 |
| L. iners (+ qPCR) | 14 (67%) | 5 (56%) | 0.79 |
|
| |||
| Moderate-Severe symptoms: | |||
|
| |||
| Vaginal dryness | 8 (38%) | 5 (56%) | 0.27 |
| Vulvar itch/burn | 6 (29%) | 4 (44%) | 0.33 |
| Vaginal itch/burn | 3 (14%) | 1 (11%) | 0.89 |
| Vaginal discharge | 6 (29%) | 4 (44%) | 0.40 |
| Pain | 5 (24%) | 1 (11%) | 0.58 |
|
| |||
| Most Bothersome Symptom (MBS) | |||
|
| |||
| Vaginal dryness | 7 (33%) | 4 (44%%) | 0.27 |
| Vulvar itch/burn | 7 (33%) | 1 (11%) | |
| Vaginal itch/burn | 2 (10%) | 0 | |
| Vaginal discharge | 0 | 1 (11%) | |
| Pain | 1 (5%) | 2 (22%) | |
| Inability to have sex | 3 (14%) | 1 (11%) | |
| Severity of MBS (median, IQR) | 6 (4, 7) | 3 (2, 5) | 0.14 |
PHQ-9 (Patient Health Questionnaire); GAD-7 (Generalized Anxiety Disorder Scale)
a
p-value calculated by chi-square or Fisher’s exact test for categorical data, Student’s t-test or Kruskall Wallis for continuous data, as appropriate.
b
Missing values for 4 in the improved group and 2 in the not improved group
c
Missing values for 6 in the improved group