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Vaginosis, Bacterial clinical trials

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NCT ID: NCT02236156 Completed - Bacterial Vaginosis Clinical Trials

Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

Start date: October 3, 2014
Phase: Phase 3
Study type: Interventional

A double-blind, phase 3 study to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV.

NCT ID: NCT02210689 Completed - BACTERIAL VAGINOSIS Clinical Trials

A Multi-center, Double-blind, Randomized Study, Comparing Clindamycin Phosphate Vaginal Cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and Both Active Treatments to a Placebo Control in the Treatment of Bacterial Vaginosis in Non-pregnant Women

Start date: January 2014
Phase: Phase 3
Study type: Interventional

A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Clindamycin phosphate vaginal cream 2% (Watson Laboratories, Inc.) to Clindesse® (Ther-Rx™, Clindamyin Phosphate Vaginal Cream 2%) and both active treatments to a placebo control in the treatment of bacterial vaginosis in non-pregnant women.

NCT ID: NCT02209519 Completed - Clinical trials for Recurrent Bacterial Vaginosis

Randomized Controlled Trial of Treatment of Male Partners of Women With BV

Start date: February 2015
Phase: Phase 3
Study type: Interventional

Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with metronidazole or placebo to compare the rates of recurrent BV in the women

NCT ID: NCT02203942 Completed - Bacterial Vaginosis Clinical Trials

Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis

VAST
Start date: July 2014
Phase: N/A
Study type: Observational

Vaginitis is the most common condition encountered in the gynecologist's office and is most commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV). Establishing the correct etiology of symptomatic vaginitis can be challenging, and the evaluation of vaginitis by physicians is often substandard. The investigators will determine whether NAAT testing will improve the diagnosis of vaginal infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).

NCT ID: NCT02197182 Terminated - Clinical trials for Bacterial Vaginosis (BV)

LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study

Start date: June 2014
Phase: Early Phase 1
Study type: Interventional

LUXSOL Cream may be useful for the treatment of bacterial Vaginosis. In this study, LUXSOL Cream is compared to a control arm group using metronidazole cream. LUXSOL is administered intravaginally for 10 days, each evening before bedtime to treat bacterial Vaginosis..

NCT ID: NCT02186145 Not yet recruiting - Bacterial Vaginosis Clinical Trials

Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections

Start date: January 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of association of metronidazole, nystatin and dexamethasone in the treatment of bacterial and fungal vaginal infections.

NCT ID: NCT02185456 Recruiting - Bacterial Vaginosis Clinical Trials

Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis

BV-LbRC
Start date: September 2014
Phase: Phase 0
Study type: Interventional

Bacterial vaginosis (BV) is the commonest form of vaginitis worldwide, affecting millions of women. Unfortunately, recurrence rates of symptomatic BV remain extremely high, 30% at three months and 70-80% within a year. Given the paucity of information and data regarding pathogenesis of BV, the etiopathogenesis of recurrent bacterial vaginosis remains unknown. Accordingly, reliable, proven treatment regimens for Recurrent Bacterial Vaginosis (RBV) are not available. In 2013, the investigators published two manuscripts documenting a new qPCR based approach to BV diagnosis and potentially prognosis. The method (LbRC) measures the content of lactobacilli in vaginal samples, relative to total bacterial load. The first goal of this study are to validate that this metric is a reliable diagnostic of BV, by determining sensitivities and specificities relative to Nugent scores and Amsel criteria of healthy women and BV patients. A high LbRC score (3-4) corresponds to a healthy state. The second goal is to determine whether empirically determined "low" LbRC scores (1-2) in BV patients after treatment are indicators of recurrence, and whether preemptive action, based on this score, with more intensive treatment, delays or eliminates recurrence in these patients.

NCT ID: NCT02173184 Recruiting - Bacterial Vaginosis Clinical Trials

Safety and Efficacy Study of Gynevac Lactobacillus Vaccine in the Treatment of Bacterial Vaginosis

Start date: June 2014
Phase: Phase 3
Study type: Interventional

To investigate the efficacy (therapeutic response) of Gynevac vaccination following a 5-shot treatment period in patients with bacterial vaginosis, based on the Nugent Score and the Amsel criteria

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.