GoldenCareTM for the Treatment of Bacterial Vaginosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01762670|
Recruitment Status : Terminated (Company decided to stop study for reasons other than safety)
First Posted : January 8, 2013
Last Update Posted : February 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis||Drug: GoldenCare Drug: Metronidazole||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Randomized Study to Determine the Safety and Efficacy of GoldenCareTM for the Treatment of Bacterial Vaginosis|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: Metronidazole
Oral administration of metronidazole, 500 mg twice daily for 7 consecutive days
500 mg twice daily for 7 days
Other Name: Comparator
GoldenCare administered intravaginally for at least 6 hours at night for 7 consecutive nights.
Copper intravaginal device to treat bacterial vaginosis.
Other Name: Copper intravaginal device
- Safety and efficacy of treating BV with GoldenCare for 7 days [ Time Frame: 21 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762670
|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|
|Principal Investigator:||Ashwin Chatwani, MD||Temple University Hospital Department of OB/GYN|