Delivering tAN to Reduce HMB: The LUNA Study

Inclusion criteria

• Regularly menstruating female aged 14-45 years at time of screening
• History of menorrhagia as assessed by the Menorrhagia Screening Tool
• Stable/consistent use of current non-hormonal medications and supplements for the past three months, willingness to continue use for duration of study, and not start any new medications or homeopathic remedies
• Reliable access to an internet-enabled device to complete required questionnaires that is compatible with the study application (iOS 18 and Android 15 or greater)
• Willingness to consistently use only study-provided menstrual products throughout duration of the study
• Participant PBAC scores are ≥150 for both baseline menstruation months

Exclusion criteria

• Pregnancy within three months of enrollment
• Lactating at the time of enrollment
• Typical length of menstruation greater than 14 days
• Antifibrinolytic (i.e. tranexamic acid; Lysteda) use within 14 days of enrollment
• Known acquired bleeding disorder
• Known severe bleeding disorder (participants with mild von Willebrand disease will be eligible to participate in the study)
• Use of anticoagulants (i.e. Warfarin, Coumadin, etc.) including platelet inhibitors for 14 days prior to enrollment
• Use of prescriptive pain medications and/or use of the following analgesics: Aspirin, naproxen (Aleve), or magnesium salicylate (Doan's) during the study
• Use of the copper intrauterine device within the past three months
• Structural cause of heavy menstrual bleeding (e.g. fibroids, polyps, etc.) in medical records
• Documented thrombocytopenia within the last 12 months (platelet count ≤100,000 per microliter of blood) in medical records
• Any use of continuous hormone therapies (e.g., IUD, etc.) within three months prior to enrollment
• Use of hormone therapies that have not followed a standard 21/7 dosing regimen for at least six months prior to enrollment
• Participant has a history of chronic tobacco use or has ingested nicotine via smoking, vaping, smokeless tobacco, or nicotine patches in the past three months
• Participant has a history of epileptic seizures within the past 12 months
• Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)
• Participant has a history traumatic brain injury within the past 12 months
• Participant has had a splenectomy
• Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators) and/or uses other neurostimulators
• Participant has abnormal ear anatomy or ear infection present
• Participant has previously used auricular neurostimulation for any clinical indication
• Participant is currently or plans to be enrolled in another clinical trial during enrollment
• Participant is a ward of the state
• Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial