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GoldenCareTM for the Treatment of Bacterial Vaginosis

This study has been terminated.
(Company decided to stop study for reasons other than safety)
Sponsor:
Information provided by (Responsible Party):
CDA Research Group, Inc.
ClinicalTrials.gov Identifier:
NCT01762670
First received: January 4, 2013
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Bacterial Vaginosis
Drug: GoldenCare
Drug: Metronidazole
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized Study to Determine the Safety and Efficacy of GoldenCareTM for the Treatment of Bacterial Vaginosis

Resource links provided by NLM:


Further study details as provided by CDA Research Group, Inc.:

Primary Outcome Measures:
  • Safety and efficacy of treating BV with GoldenCare for 7 days [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 8
Study Start Date: February 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metronidazole
Oral administration of metronidazole, 500 mg twice daily for 7 consecutive days
Drug: Metronidazole
500 mg twice daily for 7 days
Experimental: GoldenCare
GoldenCare administered intravaginally for at least 6 hours at night for 7 consecutive nights.
Drug: GoldenCare
Other Name: Copper intravaginal device

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762670

Locations
United States, Michigan
Harper University Hospital Department of Infectious Diseases
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Temple University Hospital Department of OB/GYN
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
CDA Research Group, Inc.
Investigators
Principal Investigator: Ashwin Chatwani, MD Temple University Hospital Department of OB/GYN
  More Information

No publications provided

Responsible Party: CDA Research Group, Inc.
ClinicalTrials.gov Identifier: NCT01762670     History of Changes
Other Study ID Numbers: CDA 1106
Study First Received: January 4, 2013
Last Updated: July 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CDA Research Group, Inc.:
Bacterial Vaginosis
BV

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Genital Diseases, Female
Vaginal Diseases
Vaginitis
Metronidazole
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014