Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 55
Sex
Female
Study type
Interventional
Purpose
Other
Participants needed
70 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for women aged 40-55 who have high blood pressure and are going through menopause. Participants will take melatonin or a placebo for 12 weeks to see how it affects their condition.
Are You a Good Fit for This Trial?
Must not be takingMelatoninPrescription sleeping medications
Rules you outSevere daytime sleepinessHistory of suicidal ideationHistory of clinically diagnosed anemiaActive cancer
You may be able to join if
I am a woman aged 40-55 years old.
I have high blood pressure.
I have at least one ovary and an intact uterus.
I am on a stable medical regimen for at least 2 months if taking other medications.
You may not be able to join if
I am currently taking prescription sleeping medications or melatonin.
I am pregnant or breastfeeding.
I use tobacco or vaping products.
I work night shifts.
I take prescription aspirin.
I have severe lactose intolerance.
I have a history of substance use disorder.
I have active cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
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 medicatio…
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
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