Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510614
Status:
COMPLETED
Last Update Posted:
2011-02-18
First Post:
2007-08-01
Brief Title:
Tinidazole for Recurrent Bacterial Vaginosis A Pilot Study
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Tinidazole for Recurrent Bacterial Vaginosis A Pilot Study
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is being done to evaluate the use of an oral by mouth medication called tinidazole to initially treat BV and then to see if additional treatment with tinidazole keeps women from getting this infection back within 3 months Tinidazole is currently approved by the United States Food and Drug Administration FDA to treat bacterial vaginosis BV
This study will evaluate the use of tinidazole to treat a womans current BV infection and then will look at using tinidazole as a suppressive treatment taking medication regularly to attempt to decrease the bad bacteria from growing back The suppressive treatment phase will include using tinidazole twice a week compared to using placebo twice a week and then following women for recurrence of BV The purpose of this study is to determine if tinidazole suppression will prevent BV from coming back within 3 months of treatment
The investigators hypothesize that women with a history of recurrent bacterial vaginosis who are randomized to a suppressive regimen a dose of medication given on a regular basis to attempt to control the bacteria that causes bacterial vaginosis of tinidazole will have lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared to those women randomized to placebo
This study will evaluate the use of tinidazole to treat a womans current BV infection and then will look at using tinidazole as a suppressive treatment taking medication regularly to attempt to decrease the bad bacteria from growing back The suppressive treatment phase will include using tinidazole twice a week compared to using placebo twice a week and then following women for recurrence of BV The purpose of this study is to determine if tinidazole suppression will prevent BV from coming back within 3 months of treatment
The investigators hypothesize that women with a history of recurrent bacterial vaginosis who are randomized to a suppressive regimen a dose of medication given on a regular basis to attempt to control the bacteria that causes bacterial vaginosis of tinidazole will have lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared to those women randomized to placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None