View clinical trials related to Vaginosis, Bacterial.
Filter by:This is an open user study to evaluate D005 vagnial mousse with regards to user-friendliness, and measure time from start of treatment to symptom relief and measure the clarity of instructional material. The study will be conducted at seven sites in Sweden, the study population will consist of up to 100 female subjects.
Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal infections was evaluated in this randomized, three-arms, multicentral study.
This study aimed to determine the effect of the Mediterranean diet as medical nutrition therapy in addition to medical therapy in patients diagnosed with vaginitis.
The goal of this clinical trial is to learn about the vaginal microbiome in premenopausal women with recurrent bacterial vaginosis (BV). The main questions it aims to answer are: - Does using a specific vaginal care system reduce recurrence of BV? - How does using this vaginal care system change the vaginal microbiome and pH over time? Participants will: - Have their vaginal microbiome and pH tested in several ways at three timepoints: the start of the study, 12 weeks later, and 24 weeks after the start of the study - Answer questionnaires about vulvovaginal symptoms at each of these three timepoints - Use a specific vaginal care system at home for 24 weeks, consisting of an intimate wash, a vaginal moisturizing gel, and a vaginal probiotic suppository, if assigned to the intervention group Researchers will compare the group using the vaginal care system with a control group that does not use the system to see if using the system reduces risk of BV recurrence or changes the vaginal microbiome, pH, or symptoms.
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. The most prevalent is bacterial vaginosis, followed by other clinical entities such as candidiasis, trichomoniasis and non-specific vaginitis. A collection of clinical data was conducted to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vaginitis in clinical practice. A total of 111 women aged between 20 and 70 years were recruited, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with antibiotic therapy. The aim of our study was to assess the relief in vaginal symptoms and changes in the normal vaginal pH level after 3 months of treatment with Cerviron® medical device in real-life clinical practice settings.
To evaluate and compare the efficacy, activity and tolerability of a vaginal ova formulation containing tindalised cultures (Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Streptococcus thermophilus) (LOGUSGYN/CANDIDEP OVULES) and in vaginal lavage (LOGUSGYN/CANDIDEP LAVENDER) in patients with nonspecific vulvovaginitis compared to sterile saline-based vaginal irrigation (AELAV PURLING). The primary efficacy endpoint is based on the percentage of patients with therapeutic success, defined as resolution of signs and symptoms of vaginitis (total symptom score <4) at the end of treatment. For the overall assessment of clinical outcomes (resolution, improvement or failure): outcomes at the end of treatment will be considered. The treatment outcome will be measured after 5 days (V2) and after 10 days of treatment (V3) for groups A, B and C Also for group D (later, with a second randomisation, divided into groups E and F) the primary endpoint will be the same as for groups A, B, C at the visit after 30 days of treatment (V4) The treatment outcome will be measured after 5 days (V2) (after 10 days (V3) of treatment the SPT result will be re-evaluated and will be included in the secondary endpoints). The evolution of signs and symptoms of vaginitis is defined as the percentage of patients with resolution (overall score 4), improvement (decrease in overall score from baseline of 50%) or failure (decrease in overall score <50%). Ninety-one adult female subjects (aged 18-65 years) with a diagnosis of vulvovaginitis and the presence of at least two subjective symptoms and two objective signs (at least moderate) of vaginal inflammation were recruited. The study was planned with a randomised, controlled, parallel-group sequential design to test a vaginal ova formulation containing tindalised cultures (Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Streptococcus thermophilus) (LOGUSGYN/CANDIDEP OVULES) and vaginal douches (LOGUSGYN/CANDIDEP LAVENDER) in patients with non-specific vulvovaginitis to control treatment (AELAV PURLING- vaginal irrigation with sterile saline). The sequential design involves a first phase with randomisation into 4 groups (A, B, C, D) followed by a second randomisation of group D (patients with vulvovaginitis and positive for HPV at PAP test) into two subgroups (E and F). The primary efficacy endpoint is based on the resolution of vulvovaginitis signs and symptoms (total SPT symptom score at the end of the first Phase I treatment period (after 5 days of treatment) for groups A, B, C and D). For the overall assessment of clinical outcomes (resolution, improvement or failure): results at the end of treatment after 10 days (V3) will be considered as secondary endpoints. Phase II will always have the resolution of vulvovaginitis signs and symptoms (total SPT symptom score f4 at the end of treatment at 30 days (V4)) as the primary endpoint, compared to Phase I results in group D. The protocol involves 4 visits per patient over 10 days for the groups. For groups E and F only the visit at V4 after 30 days of treatment. At visit 1 (0 days, baseline visit), patients will have to sign a written informed consent before performing any procedure. Subjects will be screened for study eligibility, verifying that all inclusion criteria and no exclusion criteria are met. At V1, the investigator will collect demographic and anamnestic data and perform a vaginal swab; in case of specific growth of pathogenic organisms, patients will be treated after the 5-day follow-up visit with antibiotics or antimycotics according to the result of the antibiogram. Delivery of the information note to the GP and the study and treatment information sheet to the patient. The investigator will then assess subjective symptomatology (burning, pain, itching, vaginal dryness, dyspareunia and dysuria) Objective symptomatology (leucorrhoea, vulvar erythema, vulvar oedema and presence of abrasion/erosion) Vaginal PH PAP test. Patients will report their degree of satisfaction with the treatment using a 5-point semiquantitative scale. Patients will be interviewed to monitor adherence to the study protocol and symptom trends during the 10-day study period (groups A, B, C and D) and at 30 days (groups E, F) The safety and tolerability of the treatments will be assessed by reporting any local and anticipated adverse events
In a population of women with heightened vulvovaginal sensitivity and recurrent bacterial vaginosis (BV), the use of the Flourish HEC Vaginal Care System is being tested for prevention of BV recurrence over six months of use.
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).
Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.
The purpose of this study is to test the effectiveness Secnidazole to treat recurrent BV. Secnidazole is approved for one-time use in acute BV. In this study, the drug will be used for recurrent BV, and given weekly for 18 weeks.