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

This is a pilot, randomized, double-blind, sham-controlled study with a crossover component evaluating the Jovi Patch (powered by Signal Relief) for the management of primary dysmenorrhea-related symptoms (general menstrual discomfort).

Menstrual discomfort is common and can significantly affect quality of life. It is largely driven by prostaglandin-mediated uterine hyper-contractility, leading to pain and associated symptoms such as low back pain, nausea, fatigue, and interference with daily activities. First-line treatments are typically nonsteroidal anti-inflammatory drugs (NSAIDs); non-drug options remain limited.

The Jovi Patch is a thin, flexible, non-invasive, drug-free device that contains no wires or batteries. It incorporates conductive particle arrays (micro-metals) designed to interact with the body's electrical signals associated with pain. The proposed mechanism is that the patch provides a preferential pathway for pain-related electrical signals, thereby reducing the intensity of signals reaching the brain. The patch is applied externally to the lower abdomen and/or lower back and is intended to be worn continuously during the menstrual period (except when showering or swimming).

Approximately 50 pre-menopausal women will be randomized in a 1:3 ratio (active:sham) to wear either the active Jovi Patch or a matching sham patch during six consecutive menstrual cycles. After the first three cycles, participants originally assigned to the sham patch will cross over to the active patch for the remaining three cycles. This design allows evaluation of both parallel-group and within-subject effects.

This pilot study is not powered for definitive efficacy conclusions. It is intended to generate preliminary safety and efficacy data to inform future research and product development. The study is being conducted at Redeemer Health in Meadowbrook, Pennsylvania. Participation lasts through six menstrual cycles; the overall study is expected to take up to 12 months.