GoldenCareTM for the Treatment of Bacterial Vaginosis

Phase 1

Terminated

• Conditions: Bacterial Vaginosis
• Interventions: Drug: GoldenCare; Drug: Metronidazole

• Registration Number: NCT01762670
• Lead Sponsor: CDA Research Group, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-08
• Study Start: 2013-02
• Status Verified: 2013-07
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GoldenCare	GoldenCare	GoldenCare administered intravaginally for at least 6 hours at night for 7 consecutive nights.
Metronidazole	Metronidazole	Oral administration of metronidazole, 500 mg twice daily for 7 consecutive days

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of treating BV with GoldenCare for 7 days	21 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.

Trial Locations

Locations (2)

Harper University Hospital Department of Infectious Diseases; 🇺🇸 Detroit, Michigan, United States

Temple University Hospital Department of OB/GYN; 🇺🇸 Philadelphia, Pennsylvania, United States