Bacterial Vaginosis Clinical Trial
Official title:
An Open-Label, Randomized Study to Determine the Safety and Efficacy of GoldenCareTM for the Treatment of Bacterial Vaginosis
Verified date | July 2013 |
Source | CDA Research Group, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 8 |
Est. completion date | December 2013 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Harper University Hospital Department of Infectious Diseases | Detroit | Michigan |
United States | Temple University Hospital Department of OB/GYN | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
CDA Research Group, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 21 days | No |
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