Effects of melatonin on heart health during menopause
Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
This study is testing if taking melatonin for 12 weeks can help improve heart health in women aged 40-55 who are going through perimenopause and have high blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 40 Years to 55 Years |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06826755 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of 12 weeks of melatonin supplementation on cardiovascular disease mechanisms in women experiencing perimenopause and hypertension. Participants will receive either melatonin or a placebo to assess changes in blood pressure and related cardiovascular markers. The study aims to determine if melatonin can provide a therapeutic benefit during this transitional phase of menopause. The trial is designed to include women aged 40-55 who meet specific criteria regarding their menstrual cycle and hypertension status.
Who should consider this trial
Good fit: Ideal candidates are women aged 40-55 in the menopause transition with a diagnosis of hypertension.
Not a fit: Patients who are currently using prescription sleeping medications or hormonal contraceptives may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for managing hypertension in women undergoing menopause.
How similar studies have performed: While there is limited research specifically on melatonin for cardiovascular health in menopause, similar studies on melatonin's effects on hypertension have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Naima Covassin, Ph.D. — Mayo Clinic
- Study coordinator: Perimenopause Study Team
- Email: PerimenopauseStdy@mayo.edu
- Phone: 507-255-8897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.