Back to resultsGoldenCareTM for the Treatment of Bacterial Vaginosis
Primary Purpose
Bacterial Vaginosis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GoldenCare
Metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginosis focused on measuring Bacterial Vaginosis, BV
Eligibility Criteria
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.
Sites / Locations
- Harper University Hospital Department of Infectious Diseases
- Temple University Hospital Department of OB/GYN
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Metronidazole
GoldenCare
Arm Description
Oral administration of metronidazole, 500 mg twice daily for 7 consecutive days
GoldenCare administered intravaginally for at least 6 hours at night for 7 consecutive nights.
Outcomes
Primary Outcome Measures
Safety and efficacy of treating BV with GoldenCare for 7 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01762670
First Posted
January 4, 2013
Last Updated
February 2, 2015
Sponsor
CDA Research Group, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01762670
Brief Title
GoldenCareTM for the Treatment of Bacterial Vaginosis
Official Title
An Open-Label, Randomized Study to Determine the Safety and Efficacy of GoldenCareTM for the Treatment of Bacterial Vaginosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Why Stopped
Company decided to stop study for reasons other than safety
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CDA Research Group, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
Bacterial Vaginosis, BV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metronidazole
Arm Type
Active Comparator
Arm Description
Oral administration of metronidazole, 500 mg twice daily for 7 consecutive days
Arm Title
GoldenCare
Arm Type
Experimental
Arm Description
GoldenCare administered intravaginally for at least 6 hours at night for 7 consecutive nights.
Intervention Type
Drug
Intervention Name(s)
GoldenCare
Other Intervention Name(s)
Copper intravaginal device
Intervention Description
Copper intravaginal device to treat bacterial vaginosis.
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Other Intervention Name(s)
Comparator
Intervention Description
500 mg twice daily for 7 days
Primary Outcome Measure Information:
Title
Safety and efficacy of treating BV with GoldenCare for 7 days
Description
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.
Time Frame
21 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashwin Chatwani, MD
Organizational Affiliation
Temple University Hospital Department of OB/GYN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harper University Hospital Department of Infectious Diseases
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Temple University Hospital Department of OB/GYN
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Learn more about this trial
GoldenCareTM for the Treatment of Bacterial Vaginosis
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