Treatment of Bacterial Vaginosis

Bacterial Vaginosis Clinical Trial

Official title:

Therapy and Prevention for Sexually Associated Bacterial Vaginosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324818
• Other study ID #: R01AI048044
• Status: Completed
• Phase: Phase 4
• First received: May 9, 2006
• Last updated: February 27, 2017
• Start date: July 2002
• Est. completion date: May 2006

Study information

• Verified date: February 2017
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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}

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

• Symptomatic bacterial vaginosis

Exclusion Criteria:

• Pregnancy

• Other genital infections

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• metronidazole and azithromycin

Locations

Country	Name	City	State
United States	Jefferson County Department of Health STD Clinic	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cure of bacterial vaginosis (BV)	percent of women without BV at follow up