Table 4.
Study timeline.
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|
Study period | ||||||||
|
|
Visit 1 (baseline) | Cycle | Visit 2 | Month assessment | Final visit | ||||
| Timepoint | Enrollment (day 0) | 1st cycle | 2nd cycle | 3rd cycle | Day 78±6a | Month 4 | Month 7 | Month 10±2a | |
| Eligibility screening | ✓ |
|
|
|
|
|
|
|
|
| Medical history | ✓ |
|
|
|
|
|
|
|
|
| Informed consent | ✓ |
|
|
|
|
|
|
|
|
| Vaginal swab for lactobacilli determination | ✓ |
|
|
|
✓ |
|
|
|
|
| Amsel criteria |
|
|
|
|
|
|
|
|
|
|
|
Vaginal pH | ✓ |
|
|
|
✓ |
|
|
✓ |
|
|
Whiff test | ✓ |
|
|
|
✓ |
|
|
✓ |
|
|
Vaginal discharge | ✓ |
|
|
|
✓ |
|
|
✓ |
|
|
Clue cells | ✓ |
|
|
|
✓ |
|
|
✓ |
| Signs and symptoms of BVb |
|
|
|
|
|
|
|
|
|
|
|
Vaginal discharge | ✓ |
|
|
|
✓ |
|
|
|
|
|
Burning | ✓ |
|
|
|
✓ |
|
|
|
|
|
Erythema | ✓ |
|
|
|
✓ |
|
|
|
|
|
Dyspareunia | ✓ |
|
|
|
✓ |
|
|
|
| Patient global evaluation of performance | ✓ |
|
|
|
✓ |
|
|
|
|
| PLGGc,d administration |
|
Within the 6th and 16th day after menstrual bleeding | Immediately after the end of the previous menstrual bleeding | Immediately after the end of the previous menstrual bleeding |
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|
|
|
|
| Phone contact |
|
28±1a days after the last day of the last menses | 28±1a days after the 1st phone contact | 28±1a days after the 2nd phone contact |
|
✓ | ✓ |
|
|
| Physical examination | ✓ |
|
|
|
✓ |
|
|
|
|
| Concomitant medication recording | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Check for adverse events | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Unused PLGG returned to the investigator |
|
|
|
|
✓ |
|
|
|
|
| Diary card delivery | ✓ |
|
|
|
✓ |
|
|
|
|
| Diary card collection |
|
|
|
|
✓ |
|
|
✓ | |
aVisit window range.
bBV: bacterial vaginosis.
cPLGG: polycarbophil, lauryl glucoside, and glycerides.
dEach cycle of PLGG has a duration of 1 week as follows: 1 ovule is inserted in the vagina on day 1, 1 ovule is inserted on day 4, and 1 ovule is inserted on day 7.