Actively Recruiting
Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
Led by Mayo Clinic · Updated on 2025-11-24
70
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
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
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
P
Perimenopause Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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