GoldenCareTM for the Treatment of Bacterial Vaginosis

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.

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.