Melatonin Effects On Cardiovascular Disease Mechanisms In Midlife Women: A Randomized Clinical Trial

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 03/30/2026. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Naima Covassin, Ph.D.	Open for enrollment	Contact information: Naima Covassin 5072558897 covassin.naima@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Naima Covassin, Ph.D.

Open for enrollment

Contact information:

Naima Covassin

5072558897

covassin.naima@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials