Study on the Effect of Palomacare4 Vaginal Gel for Treating Vaginal Dysbiosis in Premenopausal Women

What this Trial Is About

The trial investigates vaginal dysbiosis in premenopausal women with elevated vaginal pH, aiming to see if a non-hormonal topical product can improve vaginal microbiota and help prevent future infections. The study includes women aged 18 to 45 with regular menstrual cycles and examines both symptomatic and asymptomatic cases of dysbiosis. The research is conducted as a multicenter, open, comparative study with random assignment to groups, sponsored by Procare Health Iberia S.L. Participants are divided into three groups symptomatic women receiving Palomacareae vaginal gel for 6 days, asymptomatic women receiving the same treatment for 6 days, and asymptomatic women under monitored follow-up without treatment. The study involves two visits an initial visit between days 9 and 15 of the menstrual cycle and a final visit within 5 days after treatment or equivalent timing for the monitoring group. The trial consists of a pilot phase with 30 patients and an extension phase adding 60 more, totaling 90 participants. During the approximately 11-12 day study period, researchers will assess the effect of Palomacareae vaginal gel on vaginal microbiota, symptoms, vaginal pH, user satisfaction, and safety. Evaluations include diagnostic tests and symptom monitoring at both visits. Participants will be closely followed for tolerability and response to treatment, with outcomes measured by vaginal microbiota changes and symptom improvement recorded through the study duration.

A Multicenter, Open, Comparative Study on Vaginal Dysbiosis in Premenopausal Women (DISPALOMA)