Table 2.
Change in Vaginal Maturation Index (VMI), the primary variable, in the Controlled phase
|
Change in VMI at visit C2
|
||||
|---|---|---|---|---|
| n | Mean | SD | p Value | |
| Intention-to-treat | ||||
| Estriol–lactobacilli | 44 | 35.2% | 21.7% | < 0.001 |
| Placebo | 44 | 9.9% | 14.5% | |
| Per-protocol set | ||||
| Estriol–lactobacilli | 44 | 35.2% | 21.7% | < 0.001 |
| Placebo | 43 | 10.2% | 14.6% | |
SD, standard deviation