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Melatonin may tame blood pressure during menopause transition

NCT ID NCT06826755

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 2 times

Summary

This study looks at whether taking melatonin for 12 weeks can help lower blood pressure in women going through menopause who already have high blood pressure. Researchers will measure nighttime blood pressure and check for changes in stress markers. The goal is to find a simple, natural option to support heart health during this life stage.

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

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

40 to 55 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 * Age 40-55 years old * Female individuals with intact uterus and at least one ovary * Hypertension o Defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office SBP/DBP ≥130/80 mmHg * On stable medical regimen (≥ 2 months) if taking other medications Exclusion Criteria * Prescription sleeping medications or melatonin supplementation * Pregnant or lactating * Use of tobacco, nicotine or vaping products * Night shift work * On prescription aspirin * Severe lactose intolerance * History of substance use disorder * History of suicidal ideation * History of clinically diagnosed anemia (within the past 5 years) or low hemoglobin levels (\<11.6 g/dL) within the past 12 months * Active cancer * Severe daytime sleepiness (score \>15 at the Epworth Sleepiness Scale \[ESS\])81 * Current or recent (within the past 2 months) participation in other research studies at the discretion of study investigators * Inability to provide written consent and/or to speak and read English * Any other medical, geographic, or social factor making study participation impractical

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Conditions

The condition(s) this trial relates to.

hypertensive disorder

As listed by the trial registrant

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

Hypertension Perimenopause

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

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