Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CDA Research Group, Inc.
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.
Age
18–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
Clareo Health | GoldenCareTM for the Treatment of Bacterial Vaginosis
