drugset / Trial / NCT01762670

GoldenCareTM for the Treatment of Bacterial Vaginosis

NCT01762670

Phase 1/2 Terminated 8 enrolled CDA Research Group, Inc.
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

EvaluationDrugModalityDoseRoute
Comparator Metronidazole Small molecule 500 mg Oral

Indications