drugset / Trial / NCT01762670
GoldenCareTM for the Treatment of Bacterial Vaginosis
RandomizedParallel-groupOpen-labelTreatment
Summary
GoldenCare is a copper intravaginal device that may be useful for the treatment of symptomatic bacterial Vaginosis (BV). Standard treatment for BV is metronidazole. Although the reported cure rate is as high as 90%, the recurrence rate is 58% after 12 months. The study hypothesis is that GoldenCare will cure BV. This is a proof of concept study to collect preliminary evidence of the safety and efficacy of GoldenCare.
Timeline
- Start
- 2013-02
- Primary completion
- 2013-12
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metronidazole | Small molecule | 500 mg | Oral |