Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patien… (NCT06064851) | Clinical Trial Compass
CompletedNot Applicable
Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding in Patients With and Without Von Willebrand Disease
United States29 participantsStarted 2023-10-27
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Pregnancy within three months of enrollment
✕. Lactating at the time of enrollment
✕. Antifibrinolytic use within 30 days of enrollment
✕. Acquired bleeding disorder
What they're measuring
1
Blood loss during menses in both groups
Timeframe: Daily throughout both menstruations (up to 2 complete menstrual cycles- estimated 60 days)
2
Quality of Life in both groups
Timeframe: Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)
3
Duration and severity of dysmenorrhea in both groups
Timeframe: Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)
4
Duration of menstruation in both groups
Timeframe: Final day of each menstruation (up to 2 complete menstrual cycles- estimated 60 days)