GoldenCareTM for the Treatment of Bacterial Vaginosis

Stopped early · Phase 1/Phase 2

Conditions studied: Bacterial Vaginosis

In brief

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.

Key facts

Study ID

NCT01762670

Run by

CDA Research Group, Inc.

People needed

8

Starts

2013-02-01

Expected to finish

2013-12-01

Last updated by the study team

2015-02-03

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Harper University Hospital Department of Infectious Diseases — Detroit, Michigan, United States
• Temple University Hospital Department of OB/GYN — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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