Neurostimulation for Heavy Menstrual Bleeding
(VWD/HMB Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if transcutaneous auricular neurostimulation (tAN) can reduce heavy menstrual bleeding, lessen pain, and improve quality of life for individuals with von Willebrand Disease (VWD) or unexplained heavy menstrual bleeding. Participants will either have VWD Type 1 and be on hormone therapy or have heavy menstrual bleeding with no known cause and not be on hormone therapy. Those who typically experience long periods lasting 7 to 14 days and have a history of heavy bleeding might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance treatment options for heavy menstrual bleeding.
Do I have to stop taking my current medications for the trial?
No, you don't have to stop taking your current medications. You must not change any medications or supplements and should continue using them for the duration of the study. You also cannot start any new medications or homeopathic remedies.
What prior data suggests that transcutaneous auricular neurostimulation (tAN) is safe for heavy menstrual bleeding?
Research has shown that transcutaneous auricular neurostimulation (tAN) is generally safe. A recent review found that tAN is well-tolerated for various uses, with only mild and short-lived side effects. While some people might feel minor discomfort, serious problems are rare.
Another study confirmed the safety of tAN, noting that it usually causes only mild and temporary side effects. This suggests that most people using tAN do not experience serious or lasting issues. For those considering joining a trial involving tAN, current research indicates it is a safe option with minimal risk of side effects.12345Why are researchers excited about this trial?
Researchers are excited about transcutaneous auricular neurostimulation (tAN) for heavy menstrual bleeding because it offers a novel, non-invasive approach compared to typical treatments like hormonal therapy or surgical options. Unlike these standard methods, tAN works by stimulating nerves through the skin of the ear to potentially regulate menstrual bleeding. This technique could offer a new way to manage symptoms without the side effects associated with hormones or the recovery time needed after surgery.
What evidence suggests that transcutaneous auricular neurostimulation (tAN) is effective for heavy menstrual bleeding?
Research shows that transcutaneous auricular neurostimulation (tAN) might help reduce heavy menstrual bleeding. In animal studies, a similar nerve stimulation method reduced bleeding times and blood loss by 45–75%. This trial will evaluate tAN's effectiveness in participants with heavy menstrual bleeding, including those with von Willebrand Disease (VWD). For individuals with heavy menstrual bleeding, tAN has shown promise in reducing menstrual pain and symptoms. By stimulating the vagus nerve, it may help control bleeding and improve the overall menstrual experience. Early results suggest that tAN could be a helpful option for managing symptoms in these patients.12456
Who Is on the Research Team?
Navid Khodaparast, PhD
Principal Investigator
Chief Science Officer
Melanie McWade, PhD
Principal Investigator
Senior Director of Clinical Operations
Are You a Good Fit for This Trial?
This trial is for regularly menstruating women aged 18-45 with Type 1 von Willebrand Disease who experience heavy menstrual bleeding. Participants must have been on oral birth control for at least three months and agree to maintain their current medication regimen without starting new treatments or homeopathic remedies during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
First Menstruation (Baseline)
Participants estimate blood loss daily and assess dysmenorrhea and quality of life without active tAN treatment
Second Menstruation (Active tAN)
Participants self-administer tAN treatment and estimate blood loss daily, assess dysmenorrhea and quality of life
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transcutaneous Auricular Neurostimulation (tAN)
Transcutaneous Auricular Neurostimulation (tAN) is already approved in United States for the following indications:
- Relief of opioid withdrawal symptoms
Find a Clinic Near You
Who Is Running the Clinical Trial?
Five Liters, Inc.
Lead Sponsor
Spark Biomedical, Inc.
Industry Sponsor