A Study of the Jovi Patch, Powered by Signal Relief, for the Improvement of General Menstrual Discomfort

概要

This pilot study is testing whether a thin, flexible, drug-free patch called the Jovi Patch (powered by Signal Relief) can help reduce general menstrual discomfort (pain and related symptoms during periods). The patch contains no medication, wires, or batteries. It uses special micro-metal particles that are thought to interact with the body's natural electrical signals related to pain. Researchers will compare an active version of the patch to a look-alike sham (inactive) patch. About 50 pre-menopausal women ages 18-50 who have menstrual discomfort (pain score greater than 4 on a 0-10 scale) will be randomly assigned to one of two groups: Active patch group (larger group) Sham patch group Participants will wear their assigned patch during six menstrual cycles (starting the day before their period begins and continuing through the week of flow). After three cycles, women in the sham group will switch to the active patch for the remaining three cycles so researchers can also look at the effects of switching. The main question is whether more women using the active patch achieve at least a 30% reduction in their pain scores compared with those using the sham patch. The study will also track changes in how much menstrual symptoms interfere with daily life, use of pain medications, and any side effects (such as skin irritation). Participation lasts through six menstrual cycles. The overall study is expected to take up to 12 months.