Check Eligibility
Join the LUNA Study: Help test a new approach for easing symptoms of heavy menstrual bleeding, from home
Enrolling women ages 14-45 with heavy menstrual bleeding for research using a wearable investigational medical device to help reduce uncomfortable menstrual symptoms. Seeking women 14-45 with heavy periods of no known structural cause. After a 2-month baseline, wear the investigational device during periods at home for 3 months, complete brief daily surveys, with compensation up to $400 for your time and pads/tampons provided for the duration of the study.
Study overview
Your Participation
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
Next Steps
Pre-screening and Book video call with our team
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)
Medical Record Retrieval
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.
Baseline & Randomization
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.
Enrollment & Treatment
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.
Complete study participation
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.
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
Are 14-45 years old with a history of heavy menstrual bleeding with no known cause
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
Your questions answered
Heading
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Suspendisse varius enim in eros elementum tristique. Duis cursus, mi quis viverra ornare, eros dolor interdum nulla, ut commodo diam libero vitae erat. Aenean faucibus nibh et justo cursus id rutrum lorem imperdiet. Nunc ut sem vitae risus tristique posuere.