Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334633
Status:
COMPLETED
Last Update Posted:
2017-12-02
First Post:
2006-06-07
Brief Title:
Treatment of Bacterial Vaginosis BV With Tinidazole
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Tinidazole for the Treatment of Bacterial Vaginosis
Status:
COMPLETED
Status Verified Date:
2017-10
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:
We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole
Detailed Description:
Bacterial vaginosis BV is the most prevalent cause of symptomatic vaginal discharge in the US and has been associated with complications including preterm delivery of infants pelvic inflammatory disease PID urinary tract infections UTI and acquisitiontransmission of sexually transmitted diseases STDs including human immunodeficiency virus HIV Control of BV has been advocated as a means of decreasing the prevalence of these complications However the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates Although not currently licensed in the US tinidazole is an antimicrobial related to metronidazole which has shown promise for the treatment of BV in European studies and is widely used worldwide for the treatment of trichomoniasis including infections which are resistant to metronidazole We hypothesize that qualities of tinidazole such as its longer half-life and its seemingly superior side effect profile as compared to oral metronidazole will result in its being a more efficacious drug for the treatment of BV than the currently available options
The specific aims of this project are
1 To compare the efficacy of two different doses of tinidazole with oral metronidazole for the initial treatment of symptomatic BV as well as short-term recurrence rates
2 To compare the side effect profiles of tinidazole versus metronidazole in the treatment of BV
3 To compare drug levels of tinidazole and metronidazole in the vaginal secretions and correlate with microbiologic cure of BV as well as rates of recurrence
The specific aims of this project are
1 To compare the efficacy of two different doses of tinidazole with oral metronidazole for the initial treatment of symptomatic BV as well as short-term recurrence rates
2 To compare the side effect profiles of tinidazole versus metronidazole in the treatment of BV
3 To compare drug levels of tinidazole and metronidazole in the vaginal secretions and correlate with microbiologic cure of BV as well as rates of recurrence
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AI058033 | NIH | None | httpsreporternihgovquickSearchR01AI058033 |