MedTrace Logo

GoldenCareTM for the Treatment of Bacterial Vaginosis

NCT01762670 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2015-02-03

No results posted yet for this study

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.

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

GoldenCare

Copper intravaginal device to treat bacterial vaginosis.

DRUG

Metronidazole

500 mg twice daily for 7 days

Sponsors & Collaborators

  • CDA Research Group, Inc.

    lead INDUSTRY

Principal Investigators

  • Ashwin Chatwani, MD · Temple University Hospital Department of OB/GYN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01762670 on ClinicalTrials.gov