Trial | NCT01762670  Report issue

Title

GoldenCareTM for the Treatment of Bacterial Vaginosis
An Open-Label, Randomized Study to Determine the Safety and Efficacy of GoldenCareTM for the Treatment of Bacterial Vaginosis

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    8
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.
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 Started
Feb 28
2013
Primary Completion
Dec 31
2013
Study Completion
Dec 31
2013
Last Update
Feb 03
2015
Estimate

Drug GoldenCare

Copper intravaginal device to treat bacterial vaginosis.

  • Other names: Copper intravaginal device

Drug Metronidazole

500 mg twice daily for 7 days

  • Other names: Comparator

Metronidazole Active Comparator

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

GoldenCare Experimental

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

Criteria 

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.
No Results Posted