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Ear-Zap device eases heavy periods in small trial

NCT ID NCT06814028

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a small device that stimulates nerves in the ear to treat heavy menstrual bleeding. Forty women used the device during two menstrual cycles, and researchers measured changes in blood loss, pain, and quality of life. The goal was to find the right dose and see if this drug-free approach could offer relief.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

40 people

The number who actually took part.

Started

Feb 2025

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Hemorrhage Menorrhagia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Five Liters - DECENTRALIZED STUDY

    Dallas, Texas, 75252, United States

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Other studies related to the condition(s) this trial covers.