Clinical trials: Vaginitis
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
Atrophic Vaginitis, Atrophic Vulvovaginitis
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
This clinical study will evaluate the efficacy and safety of F-GYN, a sterile injectable medical device containing non-crosslinked hyaluronic acid, in adult women with moderate to severe vaginal dryness and symptoms related to…
- Conditions
- Atrophic Vaginitis, Atrophic Vulvovaginitis, Vaginal Atrophy, Dyspareunia
- Trial name
- F-GYN (NCT07701863)
- Testing
- F-GYN Non-Crosslinked Hyaluronic Acid Injectable Gel, Standard Non-Hormonal Symptomatic Care
- Where
- 3 sites in Poland
- Volunteers
- 130 people
- Sponsor
- Biovico Sp. z o.o.
Vaginal Atrophy, Atrophic Vaginitis
ASSIST-VLA: Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy
Vaginal atrophy patients receiving vaginal laser therapy will be treated with daily 7-0940® following a laser session to evaluate the safety and efficacy of the product as an adjunct treatment.
- Conditions
- Vaginal Atrophy, Atrophic Vaginitis, Genitourinary Syndrome of Menopause (GSM)
- Trial name
- ASSIST-VLA (NCT07346287)
- Testing
- 7-940
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Stratpharma AG
Bacterial Infections, Bacterial Infections and Mycoses
Large Algorithm Setting and Validation Study
In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a…
- Conditions
- Bacterial Infections, Bacterial Infections and Mycoses, Infections, Vaginitis
- Trial name
- LAVA (NCT07607470)
- Testing
- Nanopath Vaginitis Assay, BD Max™ Vaginal Panel, Cepheid Xpert® Xpress MVP
- Where
- 2 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Nanopath, Inc
Bacterial Vaginosis, Candidal Vaginitis
Efficacy and Safety of a Vaginal Ovule Medical Device for Bacterial Vaginosis and Candidal Vaginitis (ROVUL25).
This is a randomized, double-blind, placebo-controlled, two-arm parallel-group clinical study evaluating the efficacy and safety of INTIMIQUE OVULI, a Class IIa vaginal medical device, in adult women (18-60 years) diagnosed with…
- Trial name
- ROVUL-25 (NCT07703241)
- Testing
- Class IIa vaginal medical device supplied as vaginal ovules, intended as an adjuvant in prevention of vaginal infections and symptoms.
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- ROELMI HPC
Atrophic Vaginitis, Vaginal Atrophy
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term…
- Conditions
- Atrophic Vaginitis, Vaginal Atrophy, Genitourinary Syndrome of Menopause, Lichen Sclerosus of Vulva
- Trial name
- VALOR (NCT05953090)
- Testing
- 7-0940
- Where
- 14 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Stratpharma AG
Vulvovaginal Candidiasis (VVC), Yeast Vaginitis
Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)
The objective of this study is to determine clinical cure rate and safety of a proprietary Vaginal Cooling Device (VCD) in women with VCC.
- Trial name
- NCT06983041
- Testing
- vaginal cooling device
- Where
- 10 sites in United States
- Volunteers
- 55 people
- Sponsor
- Coologics, Inc
Bacterial Vaginosis
A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women
This is a Phase Ia single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, Pharmacokinetic of GenSci142 in Chinese healthy women.
- Trial name
- NCT07302035
- Testing
- GenSci142
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Vulvovaginal Candidiasis
Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
This is a multi-centre, multi-national study to evaluate the clinical performance and safety of treatment with Gedea Pessary in adult women with confirmed vulvovaginal candidiasis (VVC).
- Trial name
- EpHect (NCT05507333)
- Testing
- pHyph generation II
- Where
- 4 sites in Sweden
- Volunteers
- 26 people
- Sponsor
- Gedea Biotech AB
Vulvovaginal Candidiasis
Clinical Performance of a Vaginal Pessary (pHyph) in Vulvovaginal Candidiasis
This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with vulvovaginal candidias (VVC).
- Trial name
- NCT03761628
- Testing
- pHyph generation I
- Where
- 2 sites in Sweden
- Volunteers
- 24 people
- Sponsor
- Gedea Biotech AB
Bacterial Vaginosis
Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis
This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed bacterial vaginosis (BV) according to fulfillment of at least 3…
- Trial name
- NCT03762083
- Testing
- pHyph generation I
- Where
- 2 sites in Sweden
- Volunteers
- 24 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
Vaginitis
A Study of the Efficacy and Safety of WXSH0102 in Treating VCC Patients
This study is a multicenter, randomized, double-blind, active-controlled, dose-ranging clinical trial designed to evaluate the efficacy and safety of the investigational drug compared to the active comparator in the treatment of…
- Trial name
- NCT06771063
- Where
- 2 sites in China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Cisen Pharmaceutical CO., LTD.
Bacterial Vaginosis, Vaginal Infection
Comparison of Dequalinium Chloride (Fluomizin) vs Oral Metronidazole for the Treatment of Bacterial Vaginosis
The goal of this clinical trial is to show the efficacy and safety of dequalinium chloride in the treatment of bacterial vaginosis compared to metronidazole.
- Conditions
- Bacterial Vaginosis, Vaginal Infection, Vaginal Diseases
- Trial name
- NCT05788991
- Testing
- Dequalinium Chloride, Metronidazole Oral
- Where
- 14 sites in Czechia, Poland and 1 more
- Volunteers
- 151 people
- Sponsor
- Medinova AG
Atrophic Vaginitis
Clinical Study of Vaginal Lactobacilli and Estriol (Gynoflor®) for Atrophic Vaginitis in Breast Cancer Patients
The purpose of this study is to assess the long term safety and efficacy of the vaginal application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on atrophic vaginitis in postmenopausal breast cancer…
- Trial name
- Gynoflor (NCT01370551)
- Testing
- Estriol 0.03 mg, lyophylized lactobacillus
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 16 people
- Sponsor
- Medinova AG
Vaginal Microbiota
Collection of Vaginal Microbiota Samples (VAGINOTYPE)
The aim of this study is to collect vaginal microbiota samples from healthy women who are subject to vaginal and urinary infections.
- Trial name
- VAGINOTYPE (NCT06486519)
- Where
- 2 sites in France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Lallemand Health Solutions
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
Vaginal Infection, Vaginitis
Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge
This clinical study aims to train the algorithm and assess the performance of the Ainos Flora Women's Vaginal Health Tester in identifying vaginal infections.
- Trial name
- NCT05557318
- Testing
- Vaginal swab for RT-PCR, Vaginal swab for culture, Metabolic gas signatures detected by Ainos Flora (operated by participant)
- Where
- 2 sites in Taiwan
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Taiwan Carbon Nano Technology Corporation
Colpomycosis, Bacterial Vaginosis
First in Human Study in Healthy Volunteers of Antimicrobial Peptide PL-18 Vaginal Suppositories
This is a Single-center, Randomized, Double-blind, Placebo-controlled Phase I Study to Evaluate the Safety, Tolerability and PK Profiles of Single and Multiple Ascending Doses of Antimicrobial Peptide PL-18 Vaginal Suppositories.
- Conditions
- Colpomycosis, Bacterial Vaginosis, Mixede Vaginitis
- Trial name
- NCT05340790
- Testing
- Dose 1 to 5 of Antimicrobial Peptide PL-18 Vaginal Suppositories
- Where
- Australia
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Protelight Pharmaceuticals Australia PTY LTD
Vaginitis and Vulvovaginitis
Clinical Investigation To Evaluate Cerviron Ovules® in Symptomatic Vaginitis
CYRON is a Prospective, Open-Label, Pilot, Multicentric Clinical Investigation to Evaluate the Performance and Safety of Cerviron Ovules® in the Local Treatment of Non-Specific or Endogenous, Symptomatic Vaginitis.
- Trial name
- NCT04735705
- Testing
- Cerviron
- Where
- 2 sites in Romania
- Volunteers
- 50 people
- Sponsor
- Perfect Care Distribution