Bacterial vaginosis Trials in Disease

Study on the Effectiveness and Safety of Metronidazole, Neomycin Sulfate, and Nystatin for Women with Bacterial Vaginosis and Yeast Infections

This clinical trial is comparing two different vaginal treatments for women who have either bacterial vaginosis or vulvovaginal candidiasis (a yeast infection). The study aims to determine whether a combination of three medications in pessary form works as well as an existing treatment called Tergynan vaginal tablets.

Main inclusion criteria:

• Women aged 18 to 50 years who have started menstruating
• Diagnosed with bacterial vaginosis based on specific criteria including vaginal discharge, a positive whiff test, vaginal pH greater than 4.5, presence of clue cells, and a Nugent score of seven or higher
• Or diagnosed with vulvovaginal candidiasis based on the presence of fungal structures, vaginal pH of 4.5 or less, and symptoms like itching, burning, or irritation
• In general good health
• Regular menstrual cycles (21 to 35 days between periods)
• Negative pregnancy test at the start of the study if of childbearing potential
• Willing to use reliable birth control from 28 days before the study until 30 days after treatment
• Normal Pap test or negative HPV result within the last 3 years
• Willing to avoid sexual intercourse for the first 10 days of the study and use non-lubricated condoms afterward
• Willing to avoid alcohol during the 10-day treatment period and for 1 day after
• Willing to avoid using any vaginal products like douches, feminine sprays, or tampons during the study

Main exclusion criteria:

• Not having bacterial vaginosis or vulvovaginal candidiasis
• Being part of a vulnerable population, such as those with limited ability to protect their own interests
• Not meeting the specified age requirements

Focus and goal of the trial:

The study seeks to evaluate whether a combination treatment using Metronidazole, Neomycin Sulfate, and Nystatin pessaries is as effective and safe as Tergynan vaginal tablets in treating these infections. Participants will use one of these treatments once daily for 10 days. During this time, researchers will monitor how well the infections respond and check for any side effects. The main goal is to achieve both clinical and microbiological cure, meaning that symptoms disappear and the infection-causing organisms are eliminated. Follow-up visits will assess symptom relief, the need for additional treatment, and the sustainability of the cure.

Investigational drugs:

• Metronidazole: An antibiotic that disrupts DNA synthesis in bacteria, helping to eliminate bacterial infections
• Neomycin Sulfate: An antibiotic that inhibits protein synthesis, stopping bacterial growth
• Nystatin: An antifungal medication that binds to sterols in fungal cell membranes, causing the fungal cells to leak and die
• Tergynan: A combination vaginal tablet containing antimicrobial and antifungal ingredients that work together to disrupt the growth of bacteria and fungi

Participants will be required to follow specific guidelines during the study, including abstaining from sexual intercourse and alcohol consumption during the 10-day treatment period, and avoiding the use of any vaginal products. The study will help determine which treatment option provides better outcomes for women with these common vaginal infections.