Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis.
Sponsored by EMS
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
- Age greater than or equal to 18 years;
- Female participants, post-menarche;
- Clinical diagnosis of vulvovaginal candidiasis, defined as white, fluid or creamy vaginal discharge, in addition to the following findings:
- Itching and one or more of the following signs and symptoms characterized as moderate or severe: vulvar/vaginal erythema, edema, burning, irritation, and excoriation;
- Normal vaginal pH;
- Preparation of KOH or saline from a sample taken from inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or growing yeast.
Exclusion Criteria
- Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- Participation in a clinical trial in the year prior to this study;
- Pregnancy or risk of pregnancy and lactating patients;
- Known hypersensitivity to any of the formula compounds;
- Virgin participants;
- Postmenopausal participants or with vaginal atrophy;
- Participants with other vaginal infections;
- Participants with recurrent vulvovaginal candidiasis;
- Participants using immunosuppressive drugs;
- Participants diagnosed with serious systemic diseases.