drugset / Trial / NCT02236156
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
RandomizedParallel-groupQuadruple-blindPrevention
Summary
A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.
Timeline
- Start
- 2014-10-03
- Primary completion
- 2016-07-04
- Completion
- 2016-10-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SPL7013 | Other / unclassified | 5 g | Other |
| Background | Metronidazole | Small molecule | 500 mg | Oral |