Seeking women 14-45 with heavy periods of no known structural cause.Help test a new approach for easing symptoms of heavy menstrual bleeding, from home
At home: Complete daily surveys for up to 5 menstrual cycles via phone, tablet or computer. Wear an investigational non-invasive device for up to 3 menstrual cycles for 2 hours at a time each day.
Compensation
Participants can receive up to $400 for completing all study visits. Tampons and pads will be provided to you at no cost during your enrollment.
Timeline
Currently enrolling up to 88 participants across the U.S. The total study duration is about 5 months.
Study Site
From home virtually across continental US
Who Is This Study For?
Who is this study for?
You may be eligible if you meet the following requirements:
Gender
Female from birth
Age
14-45
History
Heavy menstrual bleeding with no known cause
You may qualify if…
Are 14-45 years old with a history of heavy menstrual bleeding with no known cause
You probably won't qualify if…
Are pregnant, or were pregnant in the past 3 months.
Have periods longer than 14 days.
Use an Intrauterine Device (IUD)
Have a history of chronic tobacco use
Additional eligibility criteria will be reviewed during the screening process
Pre-screening and Book video call with our team — (5 minutes) (30 minutes)
Complete a brief online questionnaire to assess initial eligibility (5 minutes). If you pass this stage you will receive study information via email to read. Book a video call to speak with our study team to consent, confirm eligibility and review study details (30 minutes). To reduce the length of the call by having the following items on hand at the start of the call: -Proof of Identification (current driver's license or passport)
2
Medical Record Retrieval — during the screening visit
This will be discussed during the screening visit. You will have the option to upload a portion of your medical records to a secure portal or sign a medical record retrieval consent form allowing the study team to request the relevant records to confirm heavy menstrual bleeding with no known cause.
3
Baseline & Randomization — two consecutive menstrual cycles
For your first two consecutive menstrual cycles you will be asked to complete daily questionnaires on each day of your cycle. The study team will then assess if you are eligible for the treatment part of the study.
4
Enrollment & Treatment — three consecutive menstrual cycles
The study period covers three consecutive menstrual cycles. All required supplies, including the device, are shipped to your home. You will also be asked to schedule a training call with the Device Specialist that will take about an hour to learn how to use the device. Complete brief daily questionnaires on your phone or device each day. Check in with the study team via a video call for about 15 minutes after your third cycle.
5
Complete study participation — 15-20 minutes
At the end of the study you will complete some final questionnaires, providing your feedback about the device and receive instructions on sending back the study device. You will also meet with the study team to complete a study exit interview in 15-20 minutes to review feedback on your experience with the device.
FAQs
Your questions answered
A clinical trial is a research study that helps develop and test new medical treatments, devices, or tests to determine if they are safe and effective. This study evaluates the effect of transcutaneous auricular neurostimulation on reducing menstrual blood loss in women and girls. The investigational study device is a small transcutaneous auricular neurostimulator that stimulates nerves around your ear by delivering mild electrical stimulation through the skin. Your participation provides data to help evaluate the device.
Spark Biomedical Inc. is the sponsor of this study. Spark Biomedical is a medical device company, looking to provide safe, effective alternatives to traditional therapies in areas like women's health. In this research, Spark Biomedical Inc. is evaluating the effect of transcutaneous auricular neurostimulation on reducing menstrual blood loss in women and girls.
Lindus Health is a contract research organization that manages clinical trials. The team coordinates study recruitment, site and virtual operations, and data collection, which may involve virtual enrollment, medical record collection, and survey completion.
Heavy menstrual bleeding affects approximately 20% of women of reproductive age in the United States. Research in this area is essential to explore whether new approaches can help women better manage heavy menstrual bleeding symptoms and reduce the impact on their daily activities and well-being.
All online surveys for this study will be collected through a HIPAA-compliant vendor. All video call visits will take place using a HIPAA-compliant teleconference platform. We may publish the results of this research; however, we will keep your name and other identifying information confidential.
If 18 or older, when you enroll, you'll sign an authorization allowing the study team to request records from your healthcare provider(s). If 14-17, when enrolled, the caregiver will sign authorization allowing the study team to request records from your healthcare provider(s).
Yes, at any time without penalty or effect on your medical care.
