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Bacterial Vaginosis clinical trials

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NCT ID: NCT02150655 Completed - Bacterial Vaginosis Clinical Trials

Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women

RVMM
Start date: September 2012
Phase: Phase 0
Study type: Interventional

The overall objective of this clinical pilot study is to determine at a random sampling time, the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects could alter pregnancy and conception outcomes. It is hypothesized that infection and toxins will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and infertility in Rwandan women. In a sub-group of subjects, a preliminary assessment of the ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a healthy state and lower environmental toxins will be completed.

NCT ID: NCT02147899 Completed - Bacterial Vaginosis Clinical Trials

A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

Start date: May 2014
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.

NCT ID: NCT02042352 Completed - Bacterial Vaginosis Clinical Trials

PNA FISH, PCR and Gram Staining for Detection of Bacterial Vaginosis - a Comparative Clinical Study in a Danish IVF Setting

Start date: January 2014
Phase: N/A
Study type: Observational

The primary aim of the present study is to investigate the vaginal microbiota of infertile women with two novel molecular based diagnostic tests for Bacterial Vaginosis, a PNA FISH and a PCR method supported with conventional Gram staining. We hypothesize that the molecular based tests will prove more efficient than conventional Gram staining and that they have a place in future IVF diagnostics.

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: 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.