Clinical trials: Bacterial Vaginosis (BV)
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.
Bacterial Vaginosis
Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis
This is a phase IIa clinical trial in women with bacterial vaginosis. This study will determine whether treatment with vaginal lactobacillus in combination with antibiotic therapy (metronidazole) is effective in colonizing the…
- Trial name
- NCT00635622
- Testing
- LACTIN-V
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Osel, Inc.
Bacterial Vaginosis (BV)
Live Double Combined Lactobacillus Capsule for Vaginal Use（IIa）
This is a mutilcenter, randomized, double-blind, Metronidazole controlled phase lIa clinical study to evaluate the safety and tolerability of dual - live lactobacilli-containing vaginal capsules for the treatment of Bacterial…
- Trial name
- BV (NCT07418996)
- Where
- China
- Volunteers
- 57 people
- Sponsor
- Guangdong Longchuangji Pharmaceutical Co., Ltd.
Bacterial Vaginosis
Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis
This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than…
- Trial name
- NCT03091777
- Testing
- GDC-229, Metronidazole Vaginal Gel 0.75%
- Where
- United States
- Volunteers
- 871 people
- Sponsor
- Balmoral Medical company
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
- NCT02236156
- Testing
- Metronidazole oral tablets 500mg, 1% SPL7013 Gel
- Where
- 30 sites in United States, Bulgaria and 4 more
- Volunteers
- 637 people
- Sponsor
- Starpharma Pty Ltd
Bacterial Vaginosis (BV)
Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial
The goal of this study is to evaluate how treatment with FB301 affects the balance of vaginal bacteria in women (aged 18-45) with bacterial vaginosis after pre-treatment with either a vaginal antiseptic wash (chlorhexidine), an…
- Trial name
- NCT07481955
- Testing
- FB 301, Chlorhexidine 0.5%, metronidazole 500 mg
- Where
- 2 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Freya Biosciences ApS
Bacterial Vaginosis (BV), Recurrent Bacterial Vaginosis
Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.
This clinical trial is looking at how well and safely the vaginal administration of Vagitab-T works . Vagitab-T is already on the market in several countries in Europe as a medical device.
- Trial name
- Vagitab (NCT06725888)
- Testing
- Vagitab -T vaginal tablets. Components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350:
- Where
- Romania
- Volunteers
- 30 people
- Sponsor
- S.I.I.T. Srl
Bacterial Vaginosis (BV)
LUXSOL(TM) Topical Cream for the Treatment of Symptomatic Bacterial Vaginosis; A Proof of Concept Study
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.
- Trial name
- NCT02197182
- Testing
- LUXSOL copper containing cream, Metronidazole gel
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- CDA Research Group, Inc.
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
Vaginosis, Bacterial
Safety, Tolerability and Efficacy of Vaginal Suppository WO3191 in the Post-treatment of Bacterial Vaginosis
Bacterial Vaginosis (BV) is a common infectious disorder and is characterized by a disturbance in the vaginal microbiological milieu.
- Trial name
- NCT02687789
- Testing
- Medical Device: WO3191, Medical Device: Vagisan® Lactic Acid
- Where
- 13 sites in Germany
- Volunteers
- 43 people
- Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
Bacterial Vaginosis (BV)
Multistrain Probiotics Against Bacterial Vaginosis
The primary aim of the study is to clarify whether and to what extent the consumption of the multistrain probiotic OMNi-BiOTiC® FLORA plus+ has a positive effect on the vaginal flora and reduces BV.
- Trial name
- NCT06888518
- Testing
- OMNi-BiOTiC® FLORA plus+, antibiotic
- Where
- Austria
- Volunteers
- 56 people
- Sponsor
- Institut AllergoSan Pharma GmbH
Bacterial Vaginosis (BV)
An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis
1. Rationale Bacterial vaginosis (BV) is caused by an overgrowth of bacteria and affects most women at some point. The infections can cause foul-smelling discharge and sometimes itching and burning.
- Trial name
- NCT07394777
- Testing
- pHyph
- Where
- 2 sites in Sweden
- Volunteers
- 32 people
- Sponsor
- Gedea Biotech AB
Vaginitis
Effects of LiveSpo X-SECRET in SupportiveTreatment of Vaginitis
Vaginitis is a common reproductive infection in women worldwide, particularly in tropical and underdeveloped countries. Traditional antibiotic treatments can disrupt the balance of beneficial bacteria, requiring repeated use…
- Trial name
- NCT06165354
- Testing
- 0.9% NaCl physiological saline, LiveSpo X-secret
- Where
- 2 sites in Vietnam
- Volunteers
- 120 people
- Sponsor
- Anabio R&D
Bacterial Vaginosis (BV)
Efficacy and Safety of Vaginal Lactobacillus Dual Probiotic Capsules in Bacterial Vaginosis
Primary Objective: To confirm that the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules for bacterial vaginosis (BV) is superior to placebo at the 21-30 day post-treatment visit (Day 21 to Day 30).
- Trial name
- BV (NCT07418957)
- Testing
- Vaginal Lactobacillus Dual Probiotic Capsules
- Where
- China
- Volunteers
- 402 people
- Sponsor
- Guangdong Longchuangji Pharmaceutical Co., Ltd.
Bacterial Vaginosis
A Phase 3 Study of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
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).
- Trial name
- NCT01577537
- Testing
- 1% SPL7013 Gel
- Volunteers
- 251 people
- Sponsor
- Starpharma Pty Ltd
Bacterial Vaginosis
PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?"
The study will assess vaginal microbiota levels before and after antibiotic treatment in females infected with Bacterial Vaginosis (BV).
- Trial name
- PreFem (NCT03187457)
- Testing
- Metronidazole, Control: no treatment
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Danisco
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.
Bacterial Vaginosis, Vulvovaginal Candidiasis
Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection
The purpose of this clinical trial is to investigate the clinical efficacy and safety of a Live Biotherapeutic Product (BGY-1601-VT) intended as a first line of treatment in cases of acute vaginal infection without upfront…
- Trial name
- ELINA (NCT06450990)
- Testing
- BGY-1601-VT
- Volunteers
- 165 people
- Sponsor
- NEXBIOME THERAPEUTICS
Chlamydia, Gonorrhea
Screening With Tampons: Evaluating Diagnostic Accuracy and HPV and Assessing Participant Views
Diagnostic trial comparing the diagnostic accuracy of the DAYE Diagnostic Tampon (DDT) with a vaginal swab (self-collected and clinician taken).
- Conditions
- Chlamydia, Gonorrhea, Bacterial Vaginosis, Human Papilloma Virus
- Trial name
- STAMP (NCT06154239)
- Testing
- DAYE Diagnostic Tampon, Vaginal self-swab, Clinician vaginal swab
- Where
- United Kingdom
- Volunteers
- 617 people, healthy volunteers welcome
- Sponsor
- Anne's Day Ltd
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