NCT06826755 · Mayo Clinic
Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Rochester, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 24, 2025 · Source of record for eligibility and locations