Table 1.
Frequency of a Healthy Vaginal Environment and Sustained Vaginal Health by Study Arm
| Occurrences | Rate per 100 person-years (95% CI) | Hazard ratio (95% CI) | |
| Healthy vaginal environmenta | |||
| All women | |||
| Intervention (n = 151) | 815 | 608 (568–652) | 1.36 (1.17–1.58) |
| Placebo (n = 151) | 635 | 454 (420–491) | 1.0 (Reference) |
| Women with a healthy vaginal environment at enrollment | |||
| Intervention (n = 59) | 365 | 676 (610–749) | 0.99 (0.84–1.17) |
| Placebo (n = 47) | 293 | 679 (605–761) | 1.0 (Reference) |
| Women without a healthy vaginal environment at enrollment | |||
| Intervention (n = 92) | 450 | 563 (513–617) | 1.63 (1.32–2.02) |
| Placebo (n = 104) | 342 | 354 (318–393) | 1.0 (Reference) |
| Sustained vaginal health b | |||
| Intervention (n = 142) | 86 | 102 (83–126) | 1.69 (1.23–2.33) |
| Placebo (n = 142) | 65 | 63 (49–80) | 1.0 (Reference) |
NOTE. CI, confidence interval.
a
Nugent score of 0–3 with no yeast on wet mount and no Trichomonas vaginalis on wet mount or culture.
b
Healthy vaginal environment at ≥3 consecutive follow-up visits.