Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von Willebrand Disease

Completed · Not applicable

Conditions studied: Von Willebrand Disease, Type 1, Heavy Menstrual Bleeding

In brief

The objectives of this study are to determine if transcutaneous auricular neurostimulation (tAN) can modulate hemostasis, improve perceived quality of life, and improve pain during the menstrual cycle of von Willebrand Disease (VWD) patients.

Key facts

Study ID

NCT06064851

Run by

Five Liters, Inc.

People needed

29

Starts

2023-10-27

Expected to finish

2025-04-18

Last updated by the study team

2025-04-27

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
• Typical length of menstruation ranging from 7 to 14 days
• History of menorrhagia as assessed by the Menstrual Bleeding Questionnaire
• For patients who have been diagnoses with von Willebrand Disease Type 1: On hormone therapy (with the exception of Nexplanon- at least three months) and willing to continue use for the duration of the study
• For participants with idiopathic heavy menstrual bleeding: No use of hormon therapy for at least the past three months
• No changes to all current medications and supplements in 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
• Antifibrinolytic use within 30 days of enrollment
• 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 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 — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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