GoldenCareTM for the Treatment of Bacterial Vaginosis

NCT01762670 | Terminated Phase 1

• 1 other identifier: CDA 1106
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bacterial Vaginosis

Keywords

Bacterial Vaginosis; BV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Metronidazole

ACTIVE COMPARATOR

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

Drug: Metronidazole

GoldenCare

EXPERIMENTAL

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

Drug: GoldenCare

Interventions

GoldenCare DRUG

Copper intravaginal device to treat bacterial vaginosis.

Also known as: Copper intravaginal device

GoldenCare

Metronidazole DRUG

500 mg twice daily for 7 days

Also known as: Comparator

Metronidazole

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• CDA Research Group, Inc.: lead

Study Sites (2)

Harper University Hospital Department of Infectious Diseases

Detroit, Michigan, 48201, United States

Location

Temple University Hospital Department of OB/GYN

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ashwin Chatwani, MD

  Temple University Hospital Department of OB/GYN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 8, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 3, 2015

Record last verified: 2013-07

Locations

US (2)