Effect of Semiconductor Embedded Wearable Sleeve on Treatment of Primary Dysmenorrhea Symptoms

Inclusion criteria

• Self-reported primary dysmenorrhea during past three menstrual cycles
• Age 18-45 inclusive at the time of consent
• Self-reported typical primary dysmenorrhea symptom pain greater than 4 on a 1-10 visual analog scale (VAS)
• History of regular menstrual cycles with a usual length of 21 to 35 days
• Willing and able to provide informed consent and adhere to study requirements

Exclusion criteria

• History of neurological conditions, including multiple sclerosis or Parkinson's disease
• Secondary dysmenorrhea including confirmed or suspected endometriosis or fibroids or intrauterine device
• Self-reported size not available in study device
• Pregnant or planning to become pregnant during the study
• Have within the past six months of enrollment, or are planning to in the next six months, start or discontinue any of the following contraceptive methods:

• intrauterine device
• oral contraceptives,
• contraceptive patch,
• implant (Nexplanon),
• shot (Depo-Provera),
• vaginal ring
• Chronic pain conditions unrelated to primary dysmenorrhea
• Auto-immune or auto-inflammatory diseases
• Has used within the last 90 days or is planning to use nicotine-containing products
• History of metabolic disorders
• Active infection (local or systemic) that, in the opinion of the investigator, would prevent usage of the device
• In the opinion of the investigator, any other criteria or condition that could increase the risk associated with study participation or study treatment or could interfere with the interpretation of study results
• Have taken any investigational drug or used any investigational device within the 30 days prior to consent.