Status:
COMPLETED
Longitudinal Study of Vaginal Flora
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Vaginal Flora
Eligibility:
FEMALE
15-44 years
Brief Summary
Bacterial vaginosis is a syndrome manifested by adverse alterations in vaginal microbial flora. It is present in 10 to 25% of women in the general population, and is the most common vaginal infection....
Detailed Description
Bacterial vaginosis is a syndrome manifested by adverse alterations in vaginal microbial flora. It is present in 10 to 25% of women in the general population, and is the most common vaginal infection....
Eligibility Criteria
Inclusion
- ELIGIBILITY CRITERIA:
- Females, age 15-44.
- Since bacterial vaginosis is primarily a condition of reproductive-age women, this study will be restricted to women regarded by demographers as reproductive age.
- Non-pregnant women whose last menstrual period is later than expected will undergo a urine pregnancy test. Women who become pregnant while on study will complete their next regularly scheduled study visit, following which their participation will terminate.
- EXCLUSION CRITERIA:
- Immunocompromised status
- Receiving or expected to receive in the next 12 months cytotoxic or immunosuppressive drugs.
- Receiving or expected to receive in the next 12 months one or more 30-day courses of corticosteroids.
- Congenital or acquired immune deficiency; known HIV positivity.
- Primary or secondary affective disorder, psychosis, emotional or intellectual limitations that preclude informed consent.
- Non-fluency in English.
- Post-menopausal (natural or surgical).
- Status post hysterectomy or expected to undergo hysterectomy in the next 12 months.
- Status post pelvic radiotherapy, or expected to undergo pelvic radiotherapy in the next 12 months.
- Receiving or expected to receive chronic (daily for at least 30 days) antibiotics in the next 12 months.
- Planning to move out of the area in the next 12 months.
- Participating or expected to participate during the next 12 months in a clinical trial in which antibiotics or topical microbicides will be administered in a blinded manner.
- Women who unexpectedly develop one of these conditions during their participation will continue to be followed, unless a specific contraindication arises.
Exclusion
Key Trial Info
Start Date :
April 14 1999
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 18 2010
Estimated Enrollment :
5500 Patients enrolled
Trial Details
Trial ID
NCT00340275
Start Date
April 14 1999
End Date
November 18 2010
Last Update
July 2 2017
Active Locations (1)
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1
University of Alabama
Birmingham, Alabama, United States