50 Participants NeededMy employer runs this trial

Jovi Patch for Menstrual Pain

AT
Overseen ByAshley Trymbiski
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Signal Relief
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for pre-menopausal women ages 18-50 who experience moderate to severe menstrual pain (pain score over 4 out of 10). Participants should not have any conditions or factors that would prevent them from safely using a patch on their skin.

Inclusion Criteria

Currently seeking treatment for general menstrual discomfort
I am a pre-menopausal woman between 18 and 50 years old.
My pain level is higher than 4 out of 10.
See 1 more

Exclusion Criteria

I am currently using a Jovi or Signal Relief device.
Receiving other investigational agents or on another clinical trial
Subject has implantable pain device, pacemaker, defibrillator, or other neuromodulation implantable device
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • Jovi Patch

Trial Overview

The study compares the Jovi Patch, a drug-free patch with micro-metal particles meant to reduce period pain, against an inactive look-alike patch. Women are randomly assigned and wear the patches during six menstrual cycles; some switch from sham to active halfway through.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Active Jovi PatchActive Control1 Intervention
Group II: Sham PatchPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Signal Relief

Lead Sponsor

Trials
1
Recruited
40+

Holy Redeemer Hospital

Collaborator

Trials
1
Recruited
10+