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Melatonin Effects on Cardiovascular Disease Mechanisms in the Menopause Transition: A Randomized Clinical Trial

Recruiting
40 - 55 years of age
Female
Phase N/A

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Overview

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

Inclusion Criteria

  • Age 40-55 years old
  • Female individuals with intact uterus and at least one ovary
  • Currently in the menopause transition
    • Defined as self-reported bleeding patterns encompassing the early and late perimenopause phases, in accordance with the Stages of Reproductive Aging Workshop (STRAW) Criteria:6 a difference of ≥7 days in the length of consecutive menstrual cycles which recurs within 10 cycles from the first occurrence (early menopause), or 2 to 12 months of amenorrhea (late perimenopause)
  • Hypertension
    • 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
  • Night shift work
  • Current or recent (within the past 2 months) use of hormonal contraceptives
  • Current or recent (within the past 2 months) use of hormone replacement therapy
  • On prescription aspirin
  • Severe lactose intolerance
  • History of substance use disorder
  • History of suicidal ideation
  • History of clinically diagnosed anemia 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)
  • 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

Study details

Perimenopause, Hypertension

NCT06826755

Mayo Clinic

3 May 2025

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