CompletedNot Applicable

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

United States40 participantsStarted 2025-02-14

Plain-language summary

This study is designed as an open label, single-arm, decentralized research study in which patients with idiopathic heavy menstrual bleeding will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN). Participants will be enrolled over the course of three menstruations: one baseline menstruation and two menstruations with added daily neurostimulation.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Regularly menstruating female participants between 18-45 years of age
✓. History of menorrhagia as assessed by the Menorrhagia Screening Tool
✓. 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
✓. 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
✕. Typical length of menstruation greater than 14 days
✕. Use of hormone therapy in the past three months
✕. Antifibrinolytic use within 30 days of enrollment
✕. Known inherited or acquired bleeding disorder
✕. Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including platelet inhibitors for 30 days prior to enrollment
✕. Use of the Copper intrauterine device within the past 3 months

What they're measuring

Blood loss

Timeframe: Daily throughout all three menstruations (up to 3 complete menstrual cycles - estimated 90 days)

Quality of life

Timeframe: Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)

Duration and severity of dysmenorrhea

Timeframe: Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)

Trial details

NCT IDNCT06814028

SponsorSpark Biomedical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-24

View on ClinicalTrials.gov More Heavy Menstrual Bleeding trials

Plain-language summary

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Regularly menstruating female participants between 18-45 years of age
✓. History of menorrhagia as assessed by the Menorrhagia Screening Tool
✓. 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
✓. 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
✕. Typical length of menstruation greater than 14 days
✕. Use of hormone therapy in the past three months
✕. Antifibrinolytic use within 30 days of enrollment
✕. Known inherited or acquired bleeding disorder
✕. Use of anticoagulants (i.e., Aspirin, Warfarin, Coumadin, etc.) including platelet inhibitors for 30 days prior to enrollment
✕. Use of the Copper intrauterine device within the past 3 months

What they're measuring

Blood loss

Timeframe: Daily throughout all three menstruations (up to 3 complete menstrual cycles - estimated 90 days)

Quality of life

Timeframe: Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)

Duration and severity of dysmenorrhea

Timeframe: Final day of each menstruation (up to 3 complete menstrual cycles - estimated 90 days)