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

NCT07825558 | Recruiting

• 1 other identifier: Jovi-01-25
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

General Menstrual Discomfort

Keywords

Menstrual discomfort; Jovi Patch; Signal Relief

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving at Least 30% Change in NPRS Score

  Proportion of participants who achieve at least a 30% change in their Numeric Pain Rating Scale (NPRS) score (0 = no pain, 10 = worst imaginable pain) from baseline to the end of treatment.

  Baseline to end of treatment (after 6 menstrual cycles)

Study Arms (2)

Active Jovi Patch

ACTIVE COMPARATOR

Participants receive the active Jovi Patch (powered by Signal Relief), a non-invasive, drug-free flexible wellness patch containing conductive particle arrays. The patch is worn during six consecutive menstrual cycles (or three cycles if crossing over from sham).

Device: Jovi Patch

Sham Patch

SHAM COMPARATOR

Participants receive a matching inactive (sham) patch that is identical in appearance to the active Jovi Patch but does not contain the conductive particle arrays. After three cycles, these participants cross over to the active Jovi Patch for the remaining three cycles.

Device: Sham Patch

Interventions

Jovi Patch DEVICE

Non-invasive, drug-free flexible wellness patch containing conductive particle arrays

Active Jovi Patch

Sham Patch DEVICE

Matching inactive (sham) patch that is identical in appearance to the active Jovi Patch but does not contain the conductive particle arrays

Sham Patch

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pre-menopausal female subjects aged 18 -50 years.
• Currently seeking treatment for general menstrual discomfort
• NPRS scale score \> 4 at baseline.
• Able and willing to provide informed consent in English without the assistance of an interpreter.

You may not qualify if:

• Receiving other investigational agents or on another clinical trial.
• Subject has implantable pain device, pacemaker, defibrillator, or other neuromodulation implantable device.
• Known to be pregnant, or plan to become pregnant in the next 6 months
• Current Jovi/Signal Relief users

Sponsors & Collaborators

• Signal Relief: lead
• Holy Redeemer Hospital: collaborator

Study Sites (1)

Redeemer Health

Meadowbrook, Pennsylvania, 19046, United States

RECRUITING

Central Study Contacts

Ashley Trymbiski

CONTACT

4452008090; atrymbiski@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: September 17, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)