GoldenCareTM for the Treatment of Bacterial Vaginosis

CDA Research Group

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Bacterial Vaginosis

Treatments: Drug: Metronidazole; Drug: GoldenCare

Study type: Interventional

Funder types: Industry

Identifiers

NCT01762670

CDA 1106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Metronidazole

Active Comparator group

Description:

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

Treatment:

Drug: Metronidazole

GoldenCare

Experimental group

Description:

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

Treatment:

Drug: GoldenCare