- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01762670
GoldenCareTM for the Treatment of Bacterial Vaginosis
February 2, 2015 updated by: CDA Research Group, Inc.
An Open-Label, Randomized Study to Determine the Safety and Efficacy of GoldenCareTM for the Treatment of Bacterial Vaginosis
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 Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Detroit, Michigan, United States, 48201
- Harper University Hospital Department of Infectious Diseases
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Temple University Hospital Department of OB/GYN
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Written informed consent
- Female aged 18 years or older
- Subject has clinical bacterial Vaginosis with 4 of 4 positive Amsel's criteria
- Negative pregnancy test
- For 7 day treatment period, subject agrees to refrain from using douches and intravaginal products (i.e. feminine deodorant sprays, spermicides, Nonoxynol-9 products, tampons, and condoms). Subject also agrees to refrain from taking oral or intravaginal antibiotics (unless enrolled in comparator arm),or antifungal agents during the entire study period.
Exclusion Criteria:
- Subject has another infectious or noninfectious cause of vulvovaginitis such asymptomatic candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex, human papilloma virus, atrophic vaginitis, lichen sclerosus, or genital warts.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Metronidazole
Oral administration of metronidazole, 500 mg twice daily for 7 consecutive days
|
500 mg twice daily for 7 days
Other Names:
|
Experimental: GoldenCare
GoldenCare administered intravaginally for at least 6 hours at night for 7 consecutive nights.
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Copper intravaginal device to treat bacterial vaginosis.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and efficacy of treating BV with GoldenCare for 7 days
Time Frame: 21 days
|
Successful clinical cure of BV is defined as all 4 Amsel's criteria negative at Visit 4 and a Nugent score of 0-3 at Visit 4. Success will be determined at 21 to 30 days after first treatment.
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21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ashwin Chatwani, MD, Temple University Hospital Department of OB/GYN
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
January 4, 2013
First Submitted That Met QC Criteria
January 4, 2013
First Posted (Estimate)
January 8, 2013
Study Record Updates
Last Update Posted (Estimate)
February 3, 2015
Last Update Submitted That Met QC Criteria
February 2, 2015
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDA 1106
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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