Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324818
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2006-05-09
Brief Title:
Treatment of Bacterial Vaginosis
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Therapy and Prevention for Sexually Associated Bacterial Vaginosis
Status:
COMPLETED
Status Verified Date:
2017-02
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:
We are trying to determine if longer duration of therapy with metronidazole or combination therapy of metronidazole plus azithromycin results in better cure rates for BV
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 for decreasing the prevalence of these complications The etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates Further half of all women who meet the clinical diagnostic criteria for BV are asymptomatic and treatment of these women remains controversial More detailed characterization of the origins natural history and response to therapy would supply data to guide control efforts We will approach these problems through a multifaceted interdisciplinary evaluation of women with and without BV
The specific aims and hypotheses of this project are
1 To conduct studies to determine optimal agents and duration of therapy for BV Hypothesis Longer duration of therapy and combination therapy will result in higher cure rates and lower recurrence rates of BV response to therapy differs between women with asymptomatic BV and symptomatic BV
2 To examine the role of condoms in the prevention of BV Hypothesis BV is a sexually transmitted infection thus recurrence rates of BV will be lower among women with higher condom usage rates
3 To further explore the role of Mobiluncus spp organisms strongly associated with the syndrome by utilizing specimens derived from the above studies
Hypothesis Mobiluncus is involved in the pathogenesis of BV at least in a subset of women and the persistence of this organism is associated with lack of cure and recurrence of BV
The specific aims and hypotheses of this project are
1 To conduct studies to determine optimal agents and duration of therapy for BV Hypothesis Longer duration of therapy and combination therapy will result in higher cure rates and lower recurrence rates of BV response to therapy differs between women with asymptomatic BV and symptomatic BV
2 To examine the role of condoms in the prevention of BV Hypothesis BV is a sexually transmitted infection thus recurrence rates of BV will be lower among women with higher condom usage rates
3 To further explore the role of Mobiluncus spp organisms strongly associated with the syndrome by utilizing specimens derived from the above studies
Hypothesis Mobiluncus is involved in the pathogenesis of BV at least in a subset of women and the persistence of this organism is associated with lack of cure and recurrence of BV
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