GoldenCareTM for the Treatment of Bacterial Vaginosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: GoldenCare
* Drug: Metronidazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metronidazole<br>Oral administration of metronidazole, 500 mg twice daily for 7 consecutive days | Drug: Metronidazole<br>* 500 mg twice daily for 7 days<br>* Other names: Comparator;|
| Experimental: GoldenCare<br>GoldenCare administered intravaginally for at least 6 hours at night for 7 consecutive nights. | Drug: GoldenCare<br>* Copper intravaginal device to treat bacterial vaginosis.<br>* Other names: Copper intravaginal device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacterial Vaginosis, BV