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

Launched by SPARK BIOMEDICAL, INC. · Feb 3, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called transcutaneous auricular neurostimulation (tAN) for women who experience heavy menstrual bleeding, known as menorrhagia. The goal is to see if this treatment, which stimulates specific nerves in the ear, can help reduce bleeding. Women aged 18 to 45 who have regular menstrual cycles and a history of heavy bleeding may be eligible to participate. Participants will go through the study over three menstrual cycles, with one cycle serving as a baseline and the other two involving daily neurostimulation.

If you join the trial, you will need to complete some questionnaires online and use the same brand of menstrual products throughout the study. It's important to note that certain conditions, like being pregnant, using specific medications, or having a bleeding disorder, may disqualify you from participating. This trial aims to provide more options for managing heavy menstrual bleeding and improve the quality of life for women facing this issue.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Regularly menstruating female participants between 18-45 years of age
• • 2. History of menorrhagia as assessed by the Menorrhagia Screening Tool
• • 3. 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
• • 4. Reliable access to an internet-enabled device to complete required questionnaires
• • 5. Willingness to consistently use the same brand of tampons and/or pads throughout duration of the study
• Exclusion Criteria:
• • 1. Pregnancy within three months of enrollment
• • 2. Lactating at the time of enrollment
• • 3. Typical length of menstruation greater than 14 days
• • 4. Use of hormone therapy in the past three months
• • 5. Antifibrinolytic use within 30 days of enrollment
• • 6. Known inherited or acquired bleeding disorder
• • 7. Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including platelet inhibitors for 30 days prior to enrollment
• • 8. Use of the Copper intrauterine device within the past 3 months
• • 9. Known structural cause of heavy menstrual bleeding
• • 10. Use of menstrual cups or menstrual underwear as a method of menstrual blood collection
• • 11. 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
• • 12. Participant has received a blood transfusion within 30 days prior to study
• • 13. Participant has a history of epileptic seizures
• • 14. Participant has a history of neurologic diseases or traumatic brain injury
• • 15. Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators)
• • 16. Participant has abnormal ear anatomy or ear infection present
• • 17. 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