Clinical trials: Vaginitis Gardnerella
BACTERIAL VAGINOSIS
Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis
THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS
- Trial name
- VARIANT (NCT02376972)
- Testing
- RIFAXIMIN VAGINAL TABLET 25 MG, RIFAXIMIN VAGINAL TABLET 100 MG, METROGEL VAGINAL
- Where
- United States
- Volunteers
- 392 people
- Sponsor
- Alfasigma S.p.A.
Bacterial Vaginosis
Efficacy and Safety Study of BPR-101 Capsules in Combination With Metronidazole in BV Patients
This trial employed a multicenter, randomized, double-blind, parallel, placebo-controlled design to evaluate the preventive effect of BPR-101 capsules combined with metronidazole on the recurrence of BV, as well as the cure rate…
- Trial name
- NCT07483671
- Testing
- BPR-101 capsules:Investigational product for the treatment of BV
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Chengdu Syncor Pharmaceutical Co., Ltd.
Vaginitis, Bacterial Vaginosis
Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis
Vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora.
- Trial name
- NCT05652959
- Testing
- Cerviron®
- Where
- 10 sites in Romania
- Volunteers
- 111 people
- Sponsor
- Perfect Care Distribution
Bacterial Vaginosis, Bacterial Vaginitis
Supplementation of Standard Antibiotic Therapy With Oral Probiotics for Bacterial Vaginosis
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.
- Trial name
- NCT01993524
- Testing
- probiotic
- Volunteers
- 594 people
- Sponsor
- IBSS Biomed S.A.
Bacterial Vaginosis
Clinical Performance and Safety of the Gedea Pessary in Adult Women With Bacterial Vaginosis
This is a randomised, double-blind placebo-controlled multi-centre study to evaluate clinical performance, safety and local tolerability of initial and preventive treatment with Gedea Pessary in adult women with confirmed BV.
- Trial name
- Nefertiti (NCT04640922)
- Testing
- Gedea Pessary pHyph
- Where
- 5 sites in Sweden, United Kingdom
- Volunteers
- 152 people
- Sponsor
- Gedea Biotech AB
Pregnancy
The Effect of Probiotics on Maintenance of Health in Pregnancy and Infants
This phase 2 study evaluates the effect of perinatal use of probiotics on the number of diagnosed viral, bacterial and fungal infections in pregnant women and on the maintenance of a health pregnancy.
- Trial name
- NCT03310853
- Testing
- Probiotic
- Where
- Canada
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Lallemand Health Solutions
Vaginosis, Bacterial, Bacterial Vaginosis
Study to Evaluate Efficacy and Safety of Gyntima® Balance in Preventing Recurrences of Bacterial Vaginosis
The vagina is a dynamic muscular organ whose health relies on a Lactobacillus-dominant microbiota that maintains low pH and protects against infections.
- Conditions
- Vaginosis, Bacterial, Bacterial Vaginosis, Bacterial Vaginosis (BV)
- Trial name
- GYNBAL-RBV (NCT07527572)
- Testing
- Lactobacillus gasseri KABP®064 10e9 CFU/capsule
- Volunteers
- 160 people
- Sponsor
- Kaneka Americas Holding Inc.
Bacterial Vaginosis
Pharmacokinetic Study of DARE-BV1
Single-Center, Phase 1, Single-dose PK study of DARE-BV1 (2% clindamycin phosphate vaginal gel, 100mg) under development for the treatment of bacterial vaginosis (BV).
- Trial name
- NCT05354050
- Testing
- DARE-BV1
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
Vaginal Health
Garden of Life Once Daily Women's Probiotic: Vaginal pH and Quality of Life Study
This decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (ODWP) on vaginal pH levels in healthy female populations ages 19-70 years of age across the United…
- Trial name
- NCT05330091
- Testing
- Once Daily Women's Probiotic
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Garden of Life, LLC
Bacterial Vaginosis
A Randomised, Partly-blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Bacterial Vaginosis Compared With an Untreated Control Group
This is a randomised, parallel group, partly blinded investigation to evaluate the clinical performance and safety of pHyph in adult women with bacterial vaginosis.
- Trial name
- Nefertiti 2 (NCT06123299)
- Testing
- pHyph
- Where
- 5 sites in Sweden
- Volunteers
- 61 people
- Sponsor
- Gedea Biotech AB
Bacterial Vaginosis
Prevention of Persistence of Bacterial Vaginosis
This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined…
- Trial name
- NCT00741845
- Testing
- intravaginal metronidazole
- Where
- Peru
- Volunteers
- 117 people
- Sponsor
- Embil Pharmaceutical Co. Ltd
Bacterial Vaginoses
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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.
- Trial name
- NCT04807842
- Testing
- vaginal gel
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- BioClin BV
Vaginosis, Bacterial
Diagnosing Bacterial Vaginosis/Vaginitis (BV) Using the Gynecologene Test Method
This study is designed as a prospective evaluation of the diagnostic performance of the multiplex nucleic acid-based genetic test (Gynecologene Next-Generation Sequencing test) to identify known significant causative organisms in…
- Trial name
- SAGE (NCT02558179)
- Where
- 4 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- American International Biotechnology
Bacterial Vaginosis, Vaginal Candidiasis
Multi-Gyn FemiTotal for the Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis
The goal of this clinical trial is to assess the safety and efficacy of Multi-Gyn Femitotal to treat and prevent women suffering from bacterial vaginosis and vulvo vaginal candidiasis.
- Trial name
- NCT07234786
- Testing
- Multi-Gyn FemiTotal
- Where
- Mauritius
- Volunteers
- 80 people
- Sponsor
- Karo Pharma AB
Randomized, Open-label
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial…
- Conditions
- Randomized, Open-label, Safety, Tolerability
- Trial name
- NCT07663838
- Testing
- GenSci142 capsule, clindamycin phosphate vaginal cream
- Where
- 9 sites in China
- Volunteers
- 42 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Vaginosis, Bacterial, Candidiasis, Vulvovaginal
A Study to Compare the Efficacy and Safety of a Combination of Ketoconazole and Clindamycin Compared to Tetracycline/Amphotericin B Combination Cream for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis (P08077)
This is a study to compare the safety and efficacy of the use of a intravaginal ovule containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream containing a combination Tetracycline and…
- Trial name
- NCT01293643
- Testing
- 100 mg clindamycin /800 mg ketoconazole vaginal ovule, 100 mg tetracycline hydrochloride /50 mg amphotericin B cream
- Volunteers
- 99 people
- Sponsor
- Merck Sharp & Dohme LLC
Bacterial Vaginosis
Lcr35® for Bacterial Vaginosis Prevention
This is a national, multi-centre, randomized, double-blind placebo-controlled, phase III superiority trial. The main objective of the trial is to assess the efficacy of Lcr35® by comparing the mean time before the onset of the…
- Trial name
- NCT01160796
- Testing
- Lcr35®
- Where
- France
- Volunteers
- 352 people
- Sponsor
- Laboratoires Lyocentre
Bacterial Vaginosis, Candida Vaginitis
Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis
In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500…
- Trial name
- NCT06975436
- Testing
- cobas® BV/CV test, BD Max™ Vaginal Panel, Cepheid Xpert Xpress MVP
- Where
- 10 sites in United States, Bulgaria and 1 more
- Volunteers
- 738 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Vaginitis, Infectious Vaginosis
A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis
The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nystatin, metronidazole and…
- Trial name
- NCT01867164
- Testing
- Gynoclin V, Vagitrol V
- Where
- 2 sites in Mexico
- Volunteers
- 160 people
- Sponsor
- Janssen-Cilag, S.A.
Bacterial Vaginosis
Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)
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.
- Trial name
- NCT02237950
- Testing
- Metronidazole oral tablets 500mg, 1% SPL7013 Gel
- Where
- 45 sites in United States, Canada and 1 more
- Volunteers
- 586 people
- Sponsor
- Starpharma Pty Ltd