Transcutaneous auricular neurostimulation for treating heavy menstrual bleeding in women
Transcutaneous Auricular Neurostimulation as a Treatment for Women With Heavy Menstrual Bleeding: A Dose-finding Trial
This study is testing whether a new treatment called transcutaneous auricular neurostimulation can help women with heavy menstrual bleeding feel better and reduce their blood loss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Spark Biomedical, Inc. Industry-sponsored |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06814028 on ClinicalTrials.gov |
What this trial studies
This open-label, single-arm clinical study investigates the effects of transcutaneous auricular neurostimulation (tAN) on women experiencing idiopathic heavy menstrual bleeding. Participants will undergo three menstrual cycles, with the first serving as a baseline without treatment, followed by two cycles where they will self-administer tAN sessions. Blood loss will be measured using the Pictorial Bleeding Assessment Chart (PBAC), and menstrual symptoms and quality of life will be assessed using standardized scales. The goal is to determine the efficacy of tAN in reducing menstrual bleeding and improving overall well-being.
Who should consider this trial
Good fit: Ideal candidates are regularly menstruating women aged 18-45 with a history of menorrhagia.
Not a fit: Patients who are pregnant, lactating, or have a known bleeding disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for women suffering from heavy menstrual bleeding, potentially improving their quality of life.
How similar studies have performed: While the approach of using neurostimulation for menstrual issues is relatively novel, similar studies in other areas of pain management have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- Five Liters - DECENTRALIZED STUDY — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Kimi Harada
- Email: hmbstudy@fiveliters.com
- Phone: 210-404-4162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.