Treatment of Bacterial Vaginosis

Status Completed

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

Clinical Trial 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} ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00324818
Study type	Interventional
Source	University of Alabama at Birmingham
Contact
Status	Completed
Phase	Phase 4
Start date	July 2002
Completion date	May 2006

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03930745` - Suppression Of Bacterial Vaginosis (BV) [SUBVert]	Phase 2
Completed	`NCT02863536` - A Study of the New Medical Device Polybactum®	N/A
Completed	`NCT03187457` - PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"	N/A
Recruiting	`NCT02185456` - Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis	Phase 0
Completed	`NCT02150655` - Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women	Phase 0
Completed	`NCT01450462` - Vitamin D and Sexual Health	N/A
Recruiting	`NCT01558388` - Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy	Phase 4
Not yet recruiting	`NCT00889356` - Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis	Phase 3
Completed	`NCT01471457` - Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis	Phase 2/Phase 3
Completed	`NCT00545181` - Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial	N/A
Completed	`NCT00556179` - Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis	Phase 4
Completed	`NCT02236156` - Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)	Phase 3
Not yet recruiting	`NCT05434104` - The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study	N/A
Completed	`NCT01335373` - Observational Program Neo-Penotran® Forte	N/A
Completed	`NCT00752193` - Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System.	N/A
Active, not recruiting	`NCT00536848` - The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients	Phase 2/Phase 3
Completed	`NCT00510614` - Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study	Phase 0
Suspended	`NCT00207480` - Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women	Phase 1
Recruiting	`NCT05278130` - Serial Screening and Treatment of Bacterial Vaginosis Trial	N/A
Completed	`NCT02905890` - The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.