GoldenCareTM for the Treatment of Bacterial Vaginosis
This study is currently recruiting participants.
Verified January 2013 by CDA Research Group, Inc.
Sponsor:
CDA Research Group, Inc.
Information provided by (Responsible Party):
CDA Research Group, Inc.
ClinicalTrials.gov Identifier:
NCT01762670
First received: January 4, 2013
Last updated: March 5, 2013
Last verified: January 2013
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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.
| Estimated Enrollment: | 60 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01762670
Locations
| United States, Michigan | |
| Harper University Hospital Department of Infectious Diseases | Not yet recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Jack D Sobel, MD | |
| Principal Investigator: Jack D Sobel, MD | |
| United States, Pennsylvania | |
| Temple University Hospital Department of OB/GYN | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Ashwin Chatwani, MD achatwani@temple.edu | |
| Principal Investigator: Ashwin Chatwani, MD | |
Sponsors and Collaborators
CDA Research Group, Inc.
Investigators
| Principal Investigator: | Jack D Sobel, MD | Harper University Hospital Department of Infectious Diseases |
| 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: | March 5, 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 Vaginitis Vaginal Diseases Genital Diseases, Female Metronidazole Radiation-Sensitizing Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on May 21, 2013