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

Launched by AVVA PHARMACEUTICALS LTD. · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for women suffering from candidal vulvovaginitis, a common yeast infection in the vaginal area. The researchers want to find out if a combination of Clotrimazole and Lactulose is more effective and safe compared to Clotrimazole alone, which is known under the brand name Canesten®. Women who participate will be monitored for their response to the treatment over a period of time, specifically looking at their symptoms and the presence of the yeast infection on Day 25.

To be eligible for this trial, women should be between 18 and 60 years old and have been diagnosed with candidal vulvovaginitis through clinical and laboratory tests. Participants must not be pregnant or breastfeeding and should not have any other vaginal infections or serious health issues. If you decide to join, you will need to sign a consent form, and it’s important to use reliable birth control during the study and for 30 days afterward. The study is currently recruiting participants, and if you qualify, you can expect close monitoring and support from the research team throughout the trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women aged 18 to 60 years.
• • Clinically and microbiologically confirmed diagnosis of candidal vulvovaginitis.
• • Negative pregnancy test at screening.
• • Agreement to use reliable contraception throughout the study and for 30 days after its completion.
• • Signed informed consent.
• Exclusion Criteria:
• • Pregnancy or breastfeeding.
• • Diagnosed bacterial vaginosis.
• • Chronic inflammatory or atrophic diseases of the female genital organs.
• • History of malignant neoplasms.
• • Use of systemic antibiotics or antifungal drugs within 2 weeks prior to screening.