NCT06826755Recruiting
Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 10 Feb 2025
- Start date
- 23 May 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Mayo Clinic
- Diseases
- High blood pressure
- NCT number
- NCT06826755
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 23 May 2025 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prescription sleeping medications or melatonin supplementation
Other illness
- History of substance use disorder
- History of suicidal ideation
- Active cancer
Lab values
- History of clinically diagnosed anemia (within the past 5 years) or low hemoglobin levels (\<11.6 g/dL) within the past 12 months
Other
- Pregnant or lactating
- Use of tobacco, nicotine or vaping products
- Night shift work
- On prescription aspirin
- Severe lactose intolerance
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.