Melatonin Effects on Cardiovascular Disease Mechanisms in the Menopause Transition: A Randomized Clinical Trial

Mayo Clinic

Status: Enrolling

Conditions: Hypertension; Perimenopause

Treatments: Dietary Supplement: Terry Naturally® melatonin 5mg SR; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06826755

24-008966

Details and patient eligibility

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age 40-55 years old

• Female individuals with intact uterus and at least one ovary

• Currently in the menopause transition

  o Defined as self-reported bleeding patterns encompassing the early and late perimenopause phases, in accordance with modified Stages of Reproductive Aging Workshop (STRAW) Criteria:6,80 irregular menstrual cycle (early perimenopause), 2 to 12 months of amenorrhea, or a skipped cycle within the last year (late perimenopause).

• 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
• Current or recent (within the past 2 months) use of hormonal contraceptives
• Current or recent (within the past 2 months) use of hormone replacement therapy
• On prescription aspirin
• Severe lactose intolerance
• History of substance use disorder
• History of suicidal ideation
• History of clinically diagnosed anemia 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

placebo will be taken orally once daily, one hour before bedtime. Placebo will be prepared as capsules of identical appearance and taste, using lactose powder as filler.

Treatment:

Dietary Supplement: Placebo

Melatonin

Other group

Description:

Melatonin will be taken orally once daily, one hour before bedtime. The use of melatonin is not experimental but rather to observe its effects vs. placebo on cardiovascular risk measures in perimenopausal women.

Treatment:

Dietary Supplement: Terry Naturally® melatonin 5mg SR