Clinical Trials Logo

Vaginosis, Bacterial clinical trials

View clinical trials related to Vaginosis, Bacterial.

Filter by:

NCT ID: NCT02042287 Completed - Bacterial Vaginosis Clinical Trials

Treatment Comparison of Antibiotics Versus Vaginal Lactic Acid in Non-pregnant Women With Acute Symptomatic Bacterial Vaginosis

Start date: June 2014
Phase: Phase 4
Study type: Interventional

Bacterial vaginosis (BV) is the most common cause of vaginitis in women of childbearing age. Women with symptomatic BV may present with malodorous discharge that is off-white, thin, and homogenous and has a fishy smell especially after intercourse. It is of importance to treat women with BV, as this condition is associated with serious risks, such as an increased risk of preterm birth in pregnant women, and particular vulnerability to the acquisition of sexually transmitted disease (STD). The pathophysiology of BV consists of changes in the microbiologic composition of the vaginal flora. The treatment of choice for BV is oral metronidazole for 7 days. Although the available antibiotic therapies produce good results in the short term, symptomatic BV persists or recurs at 3 months in up to 50% to 70% of patients, with long-term recurrence approaching 85%. An alternative treatment option may be a vaginal acid gel which aims to optimize the vaginal milieu. The aim of this pilot study is to assess the efficacy of Gynofit® vaginal gel (lactic acid and glycogen) compared to oral metronidazole in the treatment of BV.

NCT ID: NCT01993524 Completed - Bacterial Vaginosis Clinical Trials

Supplementation of Standard Antibiotic Therapy With Oral Probiotics for Bacterial Vaginosis

Start date: March 2009
Phase: N/A
Study type: Interventional

The purpose of this study was to determine whether supplementation of standard antibiotic therapy with oral probiotic preparation prOVag containing lactic acid bacteria influences recurrence of bacterial vaginosis/vaginitis.

NCT ID: NCT01800825 Completed - Pregnancy Clinical Trials

Clindamycin to Reduce Preterm Birth in a Low Resource Setting

Start date: July 2013
Phase: Phase 4
Study type: Interventional

Preterm birth has been linked to certain types of vaginal infections. The goal of this study is to determine if giving women pregnant between 13-20 weeks with an elavated vaginal pH(evidence of this type of infection)Oral Clindamycin(an antibiotic)will have a lower rate of preterm birth compared to women given a placebo(starch)

NCT ID: NCT01697683 Completed - Clinical trials for Pregnant Women Who Test Positive for Bacterial Vaginosis

Probiotic Therapy for the Reversal of Bacterial Vaginosis in Pregnancy

ProVIP
Start date: May 2012
Phase: Phase 2
Study type: Interventional

This study will add to the current knowledge and literature on the ability of an oral lactobacilli preparation to return the vaginal flora to a normal state in pregnant women. The results will potentially serve as the basis for a multi-centre Phase III randomized clinical trial to determine the efficacy of this treatment in preventing preterm birth.

NCT ID: NCT01621399 Completed - Bacterial Vaginosis Clinical Trials

Safety and Efficacy Study to Treat Bacterial Vaginosis

Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if product 55394 is safe and efficacious for the treatment of bacterial vaginosis.

NCT ID: NCT01577537 Completed - Bacterial Vaginosis Clinical Trials

A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

Start date: April 17, 2012
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV). After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).

NCT ID: NCT01577238 Completed - Bacterial Vaginosis Clinical Trials

A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis

Start date: March 28, 2012
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV). After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).

NCT ID: NCT01471457 Completed - Bacterial Vaginosis Clinical Trials

Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis

TBVAP
Start date: September 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of this prospective, randomized, controlled study is to assess the effect of Trimo-San vaginal gel on the rate of bacterial vaginosis in women who use pessaries. Women being fitted for a pessary for the first time or not wearing a pessary for >1 year are recruited in to the study and randomized to using Trimo-San gel daily or not using Trimo-San gel. The investigators use two objective measures of bacterial vaginosis (OSOM BV blue and gram stain) and subjective questionnaires regarding the presence and effect of vaginal symptoms on the pessary user prior to pessary fitting and at 3 months post pessary fitting. The investigators hypothesize that Trimo-San gel with not significantly affect the rate of bacterial vaginosis in pessary wearers as measures by OSOM BV blue and Gram stain, but will have a positive effect on the subjective symptoms experienced by women wearing pessaries.

NCT ID: NCT01450462 Completed - Bacterial Vaginosis Clinical Trials

Vitamin D and Sexual Health

DASH
Start date: September 2011
Phase: N/A
Study type: Interventional

Bacterial vaginosis (BV) develops when the concentration of healthy Lactobacillus species in the vagina declines and is replaced by other bacterial species. BV is the most common vaginal infection worldwide, but the etiology of this complex condition is not clear. BV is associated with a 60% increased risk of HIV acquisition as well as numerous other detrimental reproductive outcomes. A profound racial disparity exists in BV prevalence in women in the United States (US): 23% of white women versus. 52% of black women have BV. The investigators hypothesize that inadequate vitamin D contributes to BV development and/or recurrence. Vitamin D is essential to immune function, serving both to stimulate mechanisms associated with pathogen elimination and to regulate immune response. According to nationally-representative data, 90% of US blacks have insufficient vitamin D levels. In two recent analyses, low vitamin D was associated with higher BV prevalence in pregnant African-Americans; a third replicated this finding in pregnant African-American and white women. The investigators wish to conduct a small, pilot randomized controlled trial (RCT) to assess the effect of vitamin D supplementation among non-pregnant, BV-positive women at a public sexually transmitted disease (STD) clinic. This small (n=150), two-arm, placebo-controlled, masked, 24-week RCT of high-dose vitamin D supplementation will inform the development of future large-scale RCT design and implementation.

NCT ID: NCT01437722 Completed - Clinical trials for Recurrent Bacterial Vaginosis (BV)

Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)

Start date: August 2011
Phase: Phase 2
Study type: Interventional

The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.