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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 55 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares taking melatonin for 12 weeks with taking a placebo, a pill with no active drug. It looks at effects linked to heart and blood vessel disease in women nearing menopause who have high blood pressure.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women ages 40–55.
  • Have a uterus and at least one ovary.
  • Have high blood pressure: a past diagnosis, use of blood pressure medicine, or an office reading of 130/80 mmHg or higher.
  • If taking other medicines, have had no changes to them for at least 2 months.

Who can't join

  • Take prescription sleep medicine, melatonin, or prescription aspirin.
  • Are pregnant or breastfeeding; use tobacco, nicotine, or vaping products; or work night shifts.
  • Have severe trouble digesting lactose, the sugar in milk, or have active cancer.
  • Have a history of substance use disorder or thoughts of suicide.
  • Had diagnosed anemia (too few healthy red blood cells) in the past 5 years, or hemoglobin below 11.6 g/dL in the past 12 months. Hemoglobin carries oxygen in the blood.
  • Have severe daytime sleepiness, with a score above 15 on the Epworth Sleepiness Scale.
  • Are in another research study now or were in one in the past 2 months, if the study team decides this rules you out.
  • Cannot give written consent or speak and read English, or have health, location, or social issues that make taking part impractical.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

MN