GoldenCareTM for the Treatment of Bacterial Vaginosis

Bacterial Vaginosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01762670
• Other study ID #: CDA 1106
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: January 4, 2013
• Last updated: February 2, 2015
• Start date: February 2013
• Est. completion date: December 2013

Study information

• Verified date: July 2013
• Source: CDA Research Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• GoldenCare
Copper intravaginal device to treat bacterial vaginosis.
• Metronidazole
500 mg twice daily for 7 days

Locations

Country	Name	City	State
United States	Harper University Hospital Department of Infectious Diseases	Detroit	Michigan
United States	Temple University Hospital Department of OB/GYN	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
CDA Research Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy of treating BV with GoldenCare for 7 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.	21 days	No