GoldenCareTM for the Treatment of Bacterial Vaginosis

Phase 2TerminatedNCT01762670

CDA Research Group, Inc.8 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bacterial Vaginosis

Interventions

GoldenCareDRUG

Copper intravaginal device to treat bacterial vaginosis.

MetronidazoleDRUG

500 mg twice daily for 7 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

Harper University Hospital Department of Infectious Diseases

Detroit, Michigan, United States

Temple University Hospital Department of OB/GYN

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 21 days

Data from ClinicalTrials.gov

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