Is NCT07326722 recruiting in Boston, MA?

Yes, NCT07326722 is currently recruiting participants at its Boston, MA location. This heavy menstrual bleeding clinical trial is actively enrolling qualified participants.

How do I join the heavy menstrual bleeding clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Heavy Menstrual Bleeding Clinical Trial in Boston, MA

About This Heavy Menstrual Bleeding Study in Boston

The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45. Participants in both cohorts will be randomized to receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN), or sham stimulation. Participants will be enrolled into the study over the course of five consecutive menstrual cycles. All study activities will occur remotely and in addition to participants' typical treatment for HMB (as allowed by the eligibility criteria). During the first two consecutive menstrual cycles (M1 - M2, "Baseline Phase"), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC), and menstrual cramp pain will be assessed with a Numerical Rating Scale (NRS), daily throughout the duration of the menstruation phase of their two baseline menstrual cycles. Menstrual symptoms will be assessed using the Cox Menstrual Symptom Scale (CMSS) and a general quality of life assessment will be conducted on the final day of menstruation using the RAND Short-Form 36 (RAND-36). Menstrual-related quality of life assessments will also be conducted on the final day of each menstruation using the Menstrual Bleeding Questionnaire (MBQ) in the adult cohort, and the adolescent version (aMBQ) in the adolescent cohort. During the following three consecutive menstruations (M3 - M5, "Treatment Phase"), participants will self-administer one 2-hour sham or active tAN session daily, beginning Day 1 of menstruation through the final day of menstruation in each menstrual cycle. Blood loss (via the PBAC) and menstrual cramp pain (via the NRS) will be assessed daily throughout the duration of each menstruation. Quality of life will be assessed with the CMSS, RAND-36, and the MBQ (adults) or aMBQ (adolescents) on the final day of each menstruation. A device usability survey will be completed at the end of M3 and M5. Participants will exit the study after the final day of M5.

Sponsor: Spark Biomedical, Inc.

Who Can Participate

Inclusion Criteria

Regularly menstruating female aged 14-45 years at time of screening

History of menorrhagia as assessed by the Menorrhagia Screening Tool

Stable/consistent use of current non-hormonal 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 that is compatible with the study application (iOS 18 and Android 15 or greater)

Willingness to consistently use only study-provided menstrual products throughout duration of the study

Participant PBAC scores are ≥150 for both baseline menstruation months

Exclusion Criteria

Pregnancy within three months of enrollment

Lactating at the time of enrollment

Typical length of menstruation greater than 14 days

Antifibrinolytic (i.e. tranexamic acid; Lysteda) use within 14 days of enrollment

Known acquired bleeding disorder

Known severe bleeding disorder (participants with mild von Willebrand disease will be eligible to participate in the study)

Use of anticoagulants (i.e. Warfarin, Coumadin, etc.) including platelet inhibitors for 14 days prior to enrollment

Use of prescriptive pain medications and/or use of the following analgesics: Aspirin, naproxen (Aleve), or magnesium salicylate (Doan's) during the study

Use of the copper intrauterine device within the past three months

Structural cause of heavy menstrual bleeding (e.g. fibroids, polyps, etc.) in medical records

Documented thrombocytopenia within the last 12 months (platelet count ≤100,000 per microliter of blood) in medical records

Any use of continuous hormone therapies (e.g., IUD, etc.) within three months prior to enrollment

Use of hormone therapies that have not followed a standard 21/7 dosing regimen for at least six months prior to enrollment

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

Participant has a history of epileptic seizures within the past 12 months

Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)

Participant has a history traumatic brain injury within the past 12 months

Participant has had a splenectomy

Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators) and/or uses other neurostimulators

Participant has abnormal ear anatomy or ear infection present

Participant has previously used auricular neurostimulation for any clinical indication

Participant is currently or plans to be enrolled in another clinical trial during enrollment

Participant is a ward of the state

Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at 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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT07326722) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Heavy Menstrual Bleeding Treatment Options in Boston, MA

If you're searching for heavy menstrual bleeding treatment options in Boston, MA, this clinical trial (NCT07326722) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heavy menstrual bleeding specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all heavy menstrual bleeding clinical trials near you to find additional studies recruiting in your area.

Heavy Menstrual Bleeding Clinical Trial in Boston, MA

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