Effects of melatonin on heart health during menopause

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using low-dose aspirin after preeclampsia to improve recovery

  This study is testing if taking low-dose aspirin for six months after having preeclampsia can help new moms recover better by improving their blood pressure and blood vessel function.

  Recruiting Phase 4 University of Pittsburgh · Pittsburgh, Pennsylvania · NCT06281665

• Understanding immune clues to depression in perimenopause

  This study tests whether immune and epigenetic changes during perimenopause help explain why some women develop depression.

  Recruiting at 3 sites Van Andel Research Institute · Grand Rapids, Michigan and 3 other locations · NCT07910552

• Hop extract vs soy isoflavone for menopausal symptoms

  This study tests whether a full-spectrum hop extract helps reduce menopausal mood symptoms better than soy isoflavones in peri- and postmenopausal women.

  Recruiting Menoclinica by Palacios · Madrid, Madrid · NCT07904390

• IMB-guided health education to boost medication taking and blood pressure control in adults with hypertension

  This study tests a health-literacy program based on Information-Motivation-Behavioral Skills to help adults with hypertension who don’t take their medicines regularly to take them more consistently and better control their blood pressure.

  Recruiting at 8 sites Bahir Dar University · Ādēt and 7 other locations · NCT07894068

• Renal Nerve Stimulation to Help Blood Pressure in AF and HFpEF

  This study tests whether stimulating the kidneys with a catheter can safely lower blood pressure in adults with atrial fibrillation and HFpEF who also have hypertension.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT07893821

• Hypertension: Does Education Help Patients Manage Blood Pressure Better?

  This study tests whether structured patient education improves blood pressure control and self-management in adults with hypertension who speak Turkish.

  Recruiting Inonu University · Batman, Center · NCT07890090

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.