Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial

Completed · Not applicable

Conditions studied: Heavy Menstrual Bleeding

In brief

This study is designed as an open label, single-arm, decentralized research study in which patients with idiopathic heavy menstrual bleeding will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN). Participants will be enrolled over the course of three menstruations: one baseline menstruation and two menstruations with added daily neurostimulation.

Key facts

Study ID

NCT06814028

Run by

Spark Biomedical, Inc.

People needed

40

Starts

2025-02-14

Expected to finish

2025-09-24

Last updated by the study team

2025-09-26

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Regularly menstruating female participants between 18-45 years of age
• History of menorrhagia as assessed by the Menorrhagia Screening Tool
• Stable/consistent use of current 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
• Willingness to consistently use the same brand of tampons and/or pads throughout duration of the study

You may not qualify if…

• Pregnancy within three months of enrollment
• Lactating at the time of enrollment
• Typical length of menstruation greater than 14 days
• Use of hormone therapy in the past three months
• Antifibrinolytic use within 30 days of enrollment
• Known inherited or acquired bleeding disorder
• Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including platelet inhibitors for 30 days prior to enrollment
• Use of the Copper intrauterine device within the past 3 months
• Known structural cause of heavy menstrual bleeding
• Use of menstrual cups or menstrual underwear as a method of menstrual blood collection
• 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 received a blood transfusion within 30 days prior to study
• Participant has a history of epileptic seizures
• Participant has a history of neurologic diseases or traumatic brain injury
• Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators)
• Participant has abnormal ear anatomy or ear infection present
• Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are 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

Where it is running

• Five Liters - DECENTRALIZED STUDY — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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