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Treatment of Bacterial Vaginosis
This study has been terminated.
Study NCT00324818   Information provided by University of Alabama at Birmingham
First Received: May 9, 2006   Last Updated: December 14, 2007   History of Changes

May 9, 2006
December 14, 2007
July 2002
 
cure of bacterial vaginosis
Same as current
Complete list of historical versions of study NCT00324818 on ClinicalTrials.gov Archive Site
 
 
 
Treatment of Bacterial Vaginosis
Therapy and Prevention for Sexually Associated Bacterial Vaginosis

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

Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission 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}

Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Bacterial Vaginosis
Drug: metronidazole and azithromycin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
600
May 2005
 

Inclusion Criteria: symptomatic bacterial vaginosis

-

Exclusion Criteria:

  • pregnancy, other genital infections
Female
16 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00324818
 
R01AI048044
University of Alabama at Birmingham
Pfizer
Principal Investigator: Jane Schwebke, MD University of Alabama at Birmingham
University of Alabama at Birmingham
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP