Clinical Trials for Vulvovaginal Candidiasis
There are currently 2 ongoing clinical trials investigating treatments for vulvovaginal candidiasis, a common yeast infection affecting the vaginal area. These studies are being conducted in Romania, Poland, and Spain, and involve testing both combination antibiotic and antifungal medications as well as new antifungal treatments compared to standard therapies.
Clinical trial locations
- Poland
- Romania
- Spain
Study on the Effectiveness and Safety of Metronidazole, Neomycin Sulfate, and Nystatin for Women with Bacterial Vaginosis and Yeast Infections
This trial is being conducted in Romania and focuses on comparing two vaginal treatments for women dealing with both bacterial vaginosis and yeast infections. The study tests whether a combination of Metronidazole, Neomycin Sulfate, and Nystatin in the form of pessaries works as well as Tergynan vaginal tablets.
Who can participate: Women aged 18 to 50 who have started menstruating and are in generally good health can join this study. To be eligible, you must be diagnosed with either bacterial vaginosis or vulvovaginal candidiasis based on specific clinical tests. For bacterial vaginosis, this includes having vaginal discharge, a positive whiff test, vaginal pH above 4.5, and the presence of clue cells. For the yeast infection, diagnosis requires the presence of fungal structures, vaginal pH of 4.5 or less, and symptoms like itching or burning. Women of childbearing age must have a negative pregnancy test and agree to use reliable birth control throughout the study. Participants must also agree to avoid sexual intercourse during the first 10 days and refrain from alcohol consumption during treatment. No vaginal products like douches, sprays, or tampons can be used during the study period.
Who cannot participate: Male patients cannot join this study. Women who do not have either bacterial vaginosis or vulvovaginal candidiasis are not eligible. Those who fall into vulnerable populations with limited ability to protect their own interests are also excluded.
What the study involves: The main goal is to determine whether the combination of Metronidazole, Neomycin Sulfate, and Nystatin is as effective and safe as Tergynan in treating these vaginal infections. Participants will use one of these treatments vaginally once daily for 10 days. Throughout the treatment period, researchers will monitor how well the infections respond and check for any side effects. Follow-up visits will assess both clinical improvement and microbiological cure, meaning both symptom relief and elimination of the infectious organisms.
Medications being tested: Metronidazole is an antibiotic that treats bacterial infections by disrupting bacterial DNA. Neomycin Sulfate is another antibiotic that stops bacterial growth by inhibiting protein synthesis. Nystatin is an antifungal medication that works against yeast by binding to fungal cell membranes and causing cell leakage. Tergynan is a combination medication in tablet form that targets both bacterial and fungal infections and serves as the comparison treatment in this study.
Study on the Effectiveness of Albaconazole and Fluconazole for Treating Acute Vaginal Yeast Infections in Women
This trial is taking place in Poland and Spain and examines the effectiveness of a new medication called Albaconazole compared to the established treatment Fluconazole and a placebo for treating acute yeast infections in the vaginal area.
Who can participate: Women who have started menstruating and have been diagnosed with acute Candida vulvovaginitis can join this study. The diagnosis requires having at least two symptoms such as itching, burning, irritation, swelling, redness, or skin damage, with at least one being of moderate intensity. A positive rapid test for Candida, a vaginal pH of 4.5 or lower, and confirmation through a positive culture test are all necessary. Participants must provide informed consent and, if able to become pregnant, must use highly effective birth control methods. Acceptable methods include condoms, diaphragms, hormonal contraception that prevents ovulation, intrauterine devices, surgical sterilization, or abstinence during the trial period.
Who cannot participate: Male patients are excluded from this study. Women outside the specified age range and those considered part of vulnerable populations requiring special protection are not eligible.
What the study involves: This is a double-blind study, meaning neither participants nor researchers know who receives which treatment until the study ends. Participants will be randomly assigned to receive either a single dose of Albaconazole, Fluconazole, or a placebo in capsule form taken by mouth. The primary goal is to determine whether symptoms are completely resolved by the end of the study, measured by achieving a symptom score of zero at the final visit. Regular check-ups will monitor health and treatment effectiveness throughout the study period.
Medications being tested: Albaconazole is an investigational antifungal medication being studied for its effectiveness against yeast infections. It works by preventing the production of ergosterol, a crucial component of fungal cell membranes, which leads to the death of the fungus. Fluconazole is a well-established antifungal medication commonly used to treat yeast infections. It works similarly by disrupting fungal cell membrane production, effectively treating the infection. This trial compares the new medication against the standard treatment to determine its effectiveness and safety.
Summary
Currently, two clinical trials are actively recruiting participants to study treatments for vulvovaginal candidiasis. The trials are geographically diverse, with one study taking place in Romania and another spanning Poland and Spain. Both studies focus on evaluating antifungal treatments, though they take different approaches. The Romanian trial examines a combination of antibiotics and antifungals administered vaginally over a 10-day period, addressing both bacterial and fungal infections simultaneously. In contrast, the study in Poland and Spain tests a single oral dose of a new antifungal medication called Albaconazole against the established treatment Fluconazole. These trials represent different treatment strategies—one using combination topical therapy and the other exploring simplified single-dose oral treatment. The research aims to provide women with more effective and convenient treatment options for this common condition.
