Actively Recruiting

Phase Not Applicable
Age: 40Years - 55Years
FEMALE
NCT06826755

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

Led by Mayo Clinic · Updated on 2025-11-24

70

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

P

Perimenopause Study Team

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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