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Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial | Clinical Trials | Clareo Health

RECRUITINGNA

Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial

NCT06826755•Mayo Clinic

View on ClinicalTrials.gov

Summary

The purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure.

Eligibility

Age

40 - 55 years

Sex

FEMALE

Healthy Volunteers

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
+4 more criteria

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Key Dates

Start Date

May 23, 2025

Primary Completion Date

September 1, 2026

Completion Date

January 1, 2027

Last Updated

November 24, 2025

Enrollment

ESTIMATED participants

Conditions

PerimenopauseHypertension

Interventions

Terry Naturally® melatonin 5mg SR

DIETARY_SUPPLEMENT

Placebo

DIETARY_SUPPLEMENT

Contacts

Perimenopause Study Team

CONTACT

507-255-8897 PerimenopauseStdy@mayo.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial

Inclusion Criteria

Exclusion Criteria

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