General Menstrual DiscomfortNCT07825558
A Study of the Jovi Patch, Powered by Signal Relief, for the Improvement of General Menstrual Discomfort
A study testing Jovi Patch in people with General Menstrual Discomfort, run by Signal Relief at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- General Menstrual Discomfort
- What is being tested?
- Jovi Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Redeemer Health
Meadowbrook, Pennsylvania, 19046
Ashley Trymbiski, 4452008090, atrymbiski@gmail.com
Stacy Krisher, MD
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- General Menstrual Discomfort
- Being tested
- Jovi Patch, Sham Patch
- Keywords
- Menstrual discomfort, Jovi Patch, Signal Relief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jovi PatchDevice
Non-invasive, drug-free flexible wellness patch containing conductive particle arrays
Sham PatchDevice
Matching inactive (sham) patch that is identical in appearance to the active Jovi Patch but does not contain the conductive particle arrays
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Sham Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to end of treatment (after 6 menstrual cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start8 May 2026
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Menstrual DiscomfortStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Signal Relief
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Holy Redeemer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825558
- Sponsor's protocol ID
- Jovi-01-25
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Jovi Patch, Powered by Signal Relief, for the Improvement of General Menstrual Discomfort
- ClinicalTrials.gov ID
- NCT07825558
- Acronym / sponsor ID
- Jovi-01-25
- Conditions
- General Menstrual Discomfort
- Keywords
- Menstrual discomfort, Jovi Patch, Signal Relief
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Signal ReliefIndustry (pharma, biotech, devices)
- Collaborators
- Holy Redeemer Hospital
- Study start
- 8 May 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Jovi Patch | Active comparator | Device: Jovi PatchParticipants 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). |
| Sham Patch | Sham comparator | Device: Sham PatchParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jovi PatchNon-invasive, drug-free flexible wellness patch containing conductive particle arrays | Device | Active Jovi Patch |
| Sham PatchMatching inactive (sham) patch that is identical in appearance to the active Jovi Patch but does not contain the conductive particle arrays | Device | Sham Patch |
Primary outcome
Proportion of Participants Achieving at Least 30% Change in NPRS Score
Time frame: Baseline to end of treatment (after 6 menstrual cycles)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jovi Patch in people with General Menstrual Discomfort, run by Signal Relief at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Trymbiski (4452008090, atrymbiski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving at Least 30% Change in NPRS Score (time frame: Baseline to end of treatment (after 6 menstrual cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.