View clinical trials related to Vulvovaginal Candidiasis.
Filter by:Women diagnosed with Vulvovaginal Candidiasis by the health care professional will be enrolled in the study. All participants should fulfil inclusion and exclusion criteria. The study product will be used for 5 days, once a day. The doctor will evaluate the patients before and at the end of the treatment.
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 VVC. The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms. A total of 26 patients are planned to be included in the study. On Day 0 (Screening, Visit 1), eligible patients will undergo a gynaecological examination, including collection of CVVS data, and vaginal samples. Patients will be provided with 6 doses of Gedea Pessary that will be self-administered as a daily treatment (Days 0 to 5). Patients will visit the clinic on Day 7 (+2 days, Visit 2) for gynaecological examinations, including collection of CVVS data for the assessment of clinical cure and reporting of AEs and concomitant medications. On Day 14 (±2 days, Visit 3), patients that did not have a clinical and mycological cure Day 7 will re-visit the clinic for additional gynaecological examinations, including collection of CVVS data for the assessment of clinical cure. Rescue treatment will be offered during visits 2 and 3, if necessary. Patients will have a final telephone follow-up on Day 25 (±3 days, Visit 4), for for reporting of AEs, concomitant medications and potential menstruation onset. Vaginal sampling for culture and sequencing, as well as vaginal pH measuremetnts will be performed at the clinic on Day 0, Day 7, and Day 14. On Day 25, patients will self-perform vaginal swabs at home for sequencing and vaginal culture. Patient questionnaires for assessing VVC symptoms, will be used during the treatment period (Days 0 to 5), 1 day after the treatment (Day 6) and on Days 11 and 25. Usability will be assessed on Day 7, also via the patient questionaire. The patient questionnaire will be based on an electronic patient reported outcomes (ePRO) system, i.e. a mobile application (ViedocMe™).
This study will treat subjects with complicated VVC who have failed prior fluconazole therapy with Ibrexafungerp for 1, 3 or 7 days of treatment.
This is a biomarker multi-centre study to validate an extraction method of fungal and bacterial DNA extracted from vaginal swabs from adult women with confirmed VVC. The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms. Vaginal samples will be examined under a microscope for yeast forms (hyphae or pseudohyphae) or budding yeast. If the Investigator assesses that the patient has VVC, based on examination and the potassium hydroxide (KOH) test, two vaginal secretion samples will be collected by a vaginal swab. One sample will be cultured to verify the presence of Candida and the other will be used for sequencing analysis of the vaginal microbiome. Samples from a total of 10 women are planned to be taken.
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 VVC. On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to VVC signs and symptoms and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing VVC symptoms, usability, and adverse events (AEs).
This is a Phase II study designed to assess the safety and efficacy of an investigational product, TOL-463, to treat vaginitis.
This is a randomized, multicenter, evaluator blinded study to evaluate the safety, tolerability, efficacy and pharmacokinetics of SCY-078 compared to Fluconazole in adult patients with moderate to severe Vulvovaginal Candidiasis (VVC) and a history of frequent episodes of VVC. Approximately 90 subjects, meeting the inclusion criteria will be enrolled and randomized in a 1:1:1 ratio to one of the 3 treatment arms: Oral SCY-078 in 2 dose regimens or oral Fluconazole. After enrollment, subjects will be evaluated on Day-5 (end of treatment visit), Day-24 (test of cure visit), Day-60, Day 90 and Day 120 (end of observation period visit) or at any time that a recurrence or clinical failure is suspected, up to the end of observation period.
A clinical study to compare the clinical efficacy of vaginal tablets containing 10mg dequalinium chloride (Fluomizin) with the clinical efficacy of 100mg clotrimazole in patients suffering from vulvovaginal candidiasis, to assess safety of the two medications during the treatment, and to evaluate women's satisfaction with the two treatments.
Vaginitis is the most common condition encountered in the gynecologist's office and is most commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV). Establishing the correct etiology of symptomatic vaginitis can be challenging, and the evaluation of vaginitis by physicians is often substandard. The investigators will determine whether NAAT testing will improve the diagnosis of vaginal infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.