Study design
ProVate
This interventional, prospective, multicenter, open-label, randomized, controlled, home-use trial tested ProVate and control devices in a sequential crossover fashion.Following screening (Fig. Study design. Screening started at visit 1, followed by a 14–16-day washout period. Visit 2 was a baseline visit for the 1st use period, with screening, randomization into either the ProVate or control group, and enrollment of eligible participants. Visit 3 was a mid-period visit to assess for compliance with study restrictions. Visit 4 was the end-visit of the 1st use period, and results obtained from this visit were compared with those obtained from visit 2. Following another 14–16 days of the washout period, the 2nd use period began, where each woman used the alternative studied device (visits 5–7), for the same length of time. A follow-up phone call to the women at 10–14 days after visit 7 marked the end of the studySymptoms were assessed during vaginal examinations and study visits, as well as based on the use diary filled out by the user.Vaginal microflora test samples were collected from all eligible participants at the beginning and end of each use period. All samples were analyzed at a central laboratory, Covance Labs (currently LabCorp).