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Vaginal Diseases clinical trials

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NCT ID: NCT04807842 Recruiting - Bacterial Vaginoses Clinical Trials

Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis

Start date: June 11, 2021
Phase: N/A
Study type: Interventional

This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control. Treatment arm 1: Multi-Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi-Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.

NCT ID: NCT04771728 Recruiting - Bacterial Vaginosis Clinical Trials

A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis

Start date: February 1, 2020
Phase: Phase 4
Study type: Interventional

The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis

NCT ID: NCT04517487 Recruiting - Bacterial Vaginoses Clinical Trials

Vaginal Microbiome Transplantation for Recurrent Bacterial Vaginosis

Start date: August 20, 2020
Phase: N/A
Study type: Interventional

Vaginal Microbiome Transplantation (VMT) may be beneficial in treating the most severe cases of recurrent and antibiotics-nonresponsive cases of BV. Recently, we completed a preliminary study in which we treated patients with recurrent and antibiotics-non-responsive, intractable BV, with VMT from healthy donors [Lev-Sagie, Nature Medicine 2019]. Four VMT recipients in this preliminary study featured a significant improvement of both clinical symptoms and dysbiotic vaginal microbiome composition and function, which persisted over a long follow-up period, while one recipient featured a partial remission. The proposed study is designed as a placebo, randomized controlled trial, and is aimed to further assess whether VMT may serve as a viable option in symptomatic, intractable BV. In the suggested study, we plan to compare transplantation of: 1) vaginal fluid from healthy donors, and 2) autologous transplantation, of the patient's own vaginal fluid.

NCT ID: NCT04287504 Recruiting - Preterm Birth Clinical Trials

Point-of-care Tests for Bacterial Vaginosis and Candidosis

Start date: February 14, 2020
Phase:
Study type: Observational

Vaginal infection in early pregnancy is associated with an increased risk of spontaneous preterm delivery and late miscarriage. Most studies presume that vaginal infections are responsible for up to 40% of preterm birth. Although the causative microorganisms of vaginal infections are manifold, the three pathogens most commonly associated with vaginal infections are Gardnerella vaginalis, Candida albicans and Trichomonas vaginalis. The aim of this prospective study is the validation of the point-of-care tests OSOM BVBLUE for bacterial vaginosis and SavvyCheck Vaginal Yeast Test for candidosis in comparison to Gram stain.

NCT ID: NCT03500107 Recruiting - Clinical trials for Vaginosis, Bacterial

Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical Trial

Start date: October 2, 2018
Phase: N/A
Study type: Interventional

Bacterial Vaginosis (BV) is a infectious process of the female genitourinary tract, an important health issue due to the high incidence and high rate of recurrence of the infection. Therefore, new therapeutic modalities are sought with the capacity to minimize drug side effects and reduce cases of recurrence of the disease. The objective of this study is to evaluate the clinical and microbiological response of the 401+/- 5nm blue light emitting diode (LED) in the treatment of women with bacterial vaginosis. The group of women with diagnosis of bacterial vaginosis will be submitted to the light therapy. These women will also be submitted to an evaluation and examination by a ginecologist before and after the therapy. There will also be an evaluation of the clinical condition and about the effects of the light through the questionnaire answered before and after participant's treatment. It's expected that the 41 +/- 5nm LED will destroy the VB demonstrated by laboratory examination and also improves the signs and results analyzed by the gynecologist and participants.

NCT ID: NCT03357666 Recruiting - Bacterial Vaginosis Clinical Trials

Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial Vaginosis

Start date: March 22, 2016
Phase: Phase 2
Study type: Interventional

The objective of the study is to confirm the pharmacological mechanism and evaluate the efficacy and safety after HUDC-VT administration compared to placebo in patients with bacterial vaginosis. Vaginitis in adult women is extremely common and it often results in marked suffering. Epidemiologic studies indicate the high prevalence of vaginitis and the large number of causes in US. The broad-spectrum antibiotics such as metronidazole have been used as a treatment of vaginitis.However, it is not desirable using of these antibiotics caused appearance of resistant bacterium and killing normal bacterium including lactobacillus. In addition, it has been reported that long term treatment of antibiotics can be caused body toxicity through absolution by vagina. The product, HUDC_VT, is a effective and safe vaginal tablet composed glucose and sodium chloride for treatment of vaginitis by preserving healthy condition in vagina.

NCT ID: NCT03234517 Recruiting - Clinical trials for Bacterial Vaginosis Treatment

Vaginal Clindamycin Cream Plus Vaginal Probiotic for Bacterial Vaginosis

Start date: August 1, 2016
Phase: Phase 2
Study type: Interventional

Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis

NCT ID: NCT03080740 Recruiting - Bacterial Vaginosis Clinical Trials

The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet Treatment of Bacterial Vaginosis

Start date: July 2016
Phase: Phase 4
Study type: Interventional

Randomized, double blind, positive drug parallel comparison, multi-centre clinical trial to assess the Efficacy and Safety of Clindamycin palmitate hydrochloride dispersible tablet for the treatment of bacterial vaginosis

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