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

Launched by MAYO CLINIC · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how taking melatonin, a natural sleep aid, affects women who are going through the menopause transition and have high blood pressure. The study will last for 12 weeks and will compare the effects of melatonin to a placebo, which is a dummy treatment with no active ingredients. Researchers want to see if melatonin can help improve heart health during this important time in a woman's life.

To be eligible for the trial, participants need to be between 40 and 55 years old and currently experiencing perimenopause, which is the stage leading up to menopause when menstrual cycles can become irregular. Women must also have high blood pressure, either diagnosed or indicated by their blood pressure readings. However, certain conditions would prevent someone from participating, such as currently taking sleeping medications or being pregnant. If you decide to join, you will receive either melatonin or a placebo for three months, and the study will monitor your health throughout this period. This trial is an opportunity to contribute to important research that could help improve care for women during the menopause transition.

Gender

FEMALE

Eligibility criteria

• • Inclusion Criteria
• • Age 40-55 years old
• • Female individuals with intact uterus and at least one ovary
• • Currently in the menopause transition
• • o Defined as self-reported bleeding patterns encompassing the early and late perimenopause phases, in accordance with modified Stages of Reproductive Aging Workshop (STRAW) Criteria:6,80 irregular menstrual cycle (early perimenopause), 2 to 12 months of amenorrhea, or a skipped cycle within the last year (late perimenopause).
• • 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
• • 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 \[ESS\])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