This investigation is designed to demonstrate the safety and efficacy of the VR101 lubricating intravaginal ring (IVR) in treating the symptoms of vaginal dryness. In the proposed investigation, participants will use VR101 devices and sham control rings in a crossover study design. All participants who successfully complete the crossover study will be given the option to continue using VR101 for a total of 13 consecutive weeks to evaluate the long-term safety of the new device.
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Efficacy of VR101 Treatments at 28 Days Assessed by Change in VHI (Vaginal Health Index) Scores Assigned by Clinicians
Timeframe: Baseline, 28 Days
Serious Adverse Device Effects
Timeframe: Up to 24 weeks total, comprising up to 17 weeks total VR101 use and up to 4 weeks total sham control use.