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Procedure

Neurostimulation for Heavy Menstrual Bleeding (VWD/HMB Trial)

N/A

Recruiting

Led By Navid Khodaparast, PhD

Research Sponsored by Five Liters, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of von Willebrand Disease Type 1

Regularly menstruating female participants between 18-45 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if tAN can improve quality of life & reduce pain in those with von Willebrand Disease during their menstrual cycle.

Who is the study for?

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.

What is being tested?

The study tests if transcutaneous auricular neurostimulation (tAN) using the Volta System can help manage heavy menstrual bleeding, improve quality of life, and reduce pain in patients with von Willebrand Disease during their menstrual cycle.

What are the potential side effects?

Potential side effects are not specified but may include discomfort or skin irritation at the site of stimulation. As this is a non-invasive treatment, fewer systemic side effects are expected compared to drug therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with von Willebrand Disease Type 1.

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I am a woman aged 18-45 and have regular menstrual cycles.

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I have a history of heavy menstrual bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood loss during menses in both groups

Duration and severity of dysmenorrhea in both groups

Duration of menstruation in both groups

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Von Willebrand Disease (VWD) PatientsExperimental Treatment1 Intervention

Participants with VWD Type 1 who are on hormone therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN)

Group II: Heavy Menstrual Bleeding (HMB) PatientsExperimental Treatment1 Intervention

Participants with no known cause of HMB who are not on hormonal therapy. First Menstruation (baseline/no active tAN) followed by Second Menstruation (active tAN)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Volta System

2023

N/A

~30

0 / 3Eligibility criteria met