Recruiting

Melatonin

Sponsor:

Mayo Clinic

Code:

NCT06826755

Conditions

Perimenopause

Hypertension

Eligibility Criteria

Sex: Female

Age: 40 - 55

Healthy Volunteers: Not accepted

Interventions

Terry Naturally® melatonin 5mg SR

Placebo

Study Details

Brief summary:

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

Perimenopause

Hypertension

Study ID

NCT06826755

Start date

May 23, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

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.

other: Melatonin

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.

Interventions

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.

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 outcome measure

  • Change in Nocturnal Systolic Blood Pressure (SBP) [ Time Frame: Measured at baseline and at the end of the 12-week intervention ]
  • Change in Nocturnal Diastolic Blood Pressure (DBP) [ Time Frame: Measured at baseline and at the end of the 12-week intervention. ]

Central Contacts and Locations

Central contacts

Perimenopause Study Team

507-255-8897PerimenopauseStdy@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Naima Covassin, Ph.D.

Covassin.Naima@mayo.edu

Principal Investigator:

Naima Covassin, Ph.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-13.