Melatonin and Menopause

Overview

About this study

The purpose of this study is to compare the effects of melatonin supplementation vs. placebo on cardiovascular risk measures in perimenopausal women.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 40-55 years old.
  • Female individuals with intact uterus and at least one ovary.
  • Currently in the menopause transition:
    • Defined as self-reported bleeding patterns encompassing the early and late perimenopause phases, in accordance with the Stages of Reproductive Aging Workshop (STRAW) Criteria:6 a difference of ≥7 days in the length of consecutive menstrual cycles which recurs within 10 cycles from the first occurrence (early menopause), or 2 to 12 months of amenorrhea (late perimenopause)
  • Hypertension:
    • Defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office SBP/DBP ≥ 130/80 mmHg
  • On stable medical regimen (≥ 2months) if taking other medications.

Exclusion Criteria:

  • Prescription sleeping medications or melatonin supplementation
  • Pregnant or lactating
  • 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])80
  • 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 01/03/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Naima Covassin, Ph.D.

Contact us for the latest status

Contact information:

Naima Covassin Ph.D.

(507) 255-8897

Covassin.Naima@mayo.edu

More information

Publications

Publications are currently not available