Status:
COMPLETED
Pathogenesis of Bacterial Vaginosis in Women Who Have Sex With Women
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
University of Mississippi Medical Center
Louisiana State University Health Sciences Center in New Orleans
Conditions:
Vaginosis, Bacterial
Eligibility:
FEMALE
18-45 years
Brief Summary
The objectives of this study are to: (1) use cultivation-independent molecular methods to determine the sequence of microbiological events culminating in bacterial vaginosis (BV) among sexually active...
Detailed Description
Bacterial vaginosis (BV) is the most common cause of vaginal discharge in the U.S. It is associated with adverse outcomes including preterm birth, pelvic inflammatory disease, and increased risk of ac...
Eligibility Criteria
Inclusion
- Screening
- African American race
- Female Gender
- Age 18-45 years
- History of sexual activity (oral, vaginal, and/or anal) with a female sexual partner during the past 12 months
- Current female sexual partner
- English speaking
- Ability to give written informed consent
- Screening
Exclusion
- Use of antimicrobials (oral and/or vaginal) within the past 14 days
- Known HIV
- Known pregnancy
- Currently on menstrual period
- Enrollment Inclusion Criteria:
- No Amsel criteria (i.e. patient currently asymptomatic from vaginal discharge standpoint, has normal vaginal pH, negative whiff test, and no clue cells on saline microscopy)
- Nugent score of 0-3 with no Gardnerella vaginalis morphotypes noted on Gram stain
- Enrollment
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT02272231
Start Date
September 1 2014
End Date
January 1 2019
Last Update
January 7 2019
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294