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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01762670
Study type Interventional
Source CDA Research Group, Inc.
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date February 2013
Completion date December 2013

See also
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