NCT01762670

GoldenCareTM for the Treatment of Bacterial Vaginosis

An Open-Label, Randomized Study to Determine the Safety and Efficacy of GoldenCareTM for the Treatment of Bacterial Vaginosis

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: CDA Research Group, Inc. · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	GoldenCare	Copper intravaginal device to treat bacterial vaginosis.
DRUG	Metronidazole	500 mg twice daily for 7 days

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-01-08
• Last updated: 2015-02-03

Locations

2 sites across 1 country: United States