A Study of the Jovi Patch, Powered by Signal Relief, for the Improvement of General Menstrual Discomfort
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ashley Trymbiski
- Numéro de téléphone: 4452008090
- E-mail: atrymbiski@gmail.com
Lieux d'étude
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Pennsylvania
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Meadowbrook, Pennsylvania, États-Unis, 19046
- Recrutement
- Redeemer Health
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Chercheur principal:
- Stacy Krisher, MD
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Contact:
- Ashley Trymbiski
- Numéro de téléphone: 4452008090
- E-mail: atrymbiski@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Active Jovi Patch
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).
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Non-invasive, drug-free flexible wellness patch containing conductive particle arrays
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Comparateur factice: Sham Patch
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.
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Matching inactive (sham) patch that is identical in appearance to the active Jovi Patch but does not contain the conductive particle arrays
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of Participants Achieving at Least 30% Change in NPRS Score
Délai: Baseline to end of treatment (after 6 menstrual cycles)
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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.
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Baseline to end of treatment (after 6 menstrual cycles)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- Jovi-01-25
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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