Recruiting
Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
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.
ClinicalTrials.gov IDNCT06826755
PhaseNA
Enrollment70
SponsorMayo Clinic
Age40 Years
SexFEMALE
Conditions studied
Perimenopause, Hypertension
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.
Interventions
- Dietary Supplement: Terry Naturally® melatonin 5mg SR — Participants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women.
- Dietary Supplement: Placebo — Participants will take SR melatonin 5mg (or placebo) orally 1 hour before bed, for approximately 12 weeks. The study is comparing the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women.
Primary outcomes
- Change in Nocturnal Systolic Blood Pressure (SBP) (Measured at baseline and at the end of the 12-week intervention)
- Change in Nocturnal Diastolic Blood Pressure (DBP) (Measured at baseline and at the end of the 12-week intervention.)
Eligibility information
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 locations
- Mayo Clinic in Rochester, Rochester, Minnesota 55905 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.