GoldenCareTM for the Treatment of Bacterial Vaginosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-12-31

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.

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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.

Conditions

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Bacterial Vaginosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metronidazole

Oral administration of metronidazole, 500 mg twice daily for 7 consecutive days

Group Type ACTIVE_COMPARATOR

Metronidazole

Intervention Type DRUG

500 mg twice daily for 7 days

GoldenCare

GoldenCare administered intravaginally for at least 6 hours at night for 7 consecutive nights.

Group Type EXPERIMENTAL

GoldenCare

Intervention Type DRUG

Copper intravaginal device to treat bacterial vaginosis.

Interventions

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GoldenCare

Copper intravaginal device to treat bacterial vaginosis.

Intervention Type DRUG

Metronidazole

500 mg twice daily for 7 days

Intervention Type DRUG

Other Intervention Names

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Copper intravaginal device Comparator

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No