International Open-label Randomized Study Comparing Clotrimazole+Lactulose Vaginal Suppositories to Clotrimazole Alone in Adult Women with Candidal Vaginitis/Vulvovaginitis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a combination drug containing clotrimazole and lactulose compared to clotrimazole alone in adult women diagnosed with candidal vulvovaginitis. The study aims to determine if the combination drug provides better clinical and microbiological recovery by Day 25 of treatment. This trial uses an adaptive design to assess how lactulose affects fungal infections in the vagina. Participants are randomly assigned to one of three groups: one receiving vaginal suppositories with clotrimazole (100 mg) and lactulose (300 mg), another receiving vaginal tablets with clotrimazole (100 mg) alone, and a third group receiving vaginal suppositories with lactulose (300 mg) alone. The study evaluates outcomes at several visits: Day 8, Day 15, and Day 25, focusing on symptom improvement, microbiological response, and changes in vaginal bacteria. During the study, participants will undergo clinical assessments and laboratory tests to measure symptom severity and vaginal bacterial content, including molecular analysis of Lactobacillus levels. Patient satisfaction with the therapy will also be recorded. Safety and treatment responses will be monitored throughout the 25-day period, with the main result being the proportion of patients who achieve full clinical and microbiological recovery by Day 25.

Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis