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

Not Applicable

Recruiting

• Conditions: Perimenopause; Hypertension

• Registration Number: NCT06826755
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-14
• Study Start: 2025-05-23
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-09
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Nocturnal Systolic Blood Pressure (SBP)	Measured at baseline and at the end of the 12-week intervention	Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.
Change in Nocturnal Diastolic Blood Pressure (DBP)	Measured at baseline and at the end of the 12-week intervention.	Measured using 24-hour ambulatory blood pressure (ABP) monitoring, including nighttime BP levels and nocturnal BP dipping.

Secondary Outcome Measures

Name	Time	Method
Change in Oxidative Stress Markers	Measured at baseline and at the end of the 12-week intervention.	Assessed using Blood and urine samples analyzed by Mayo Clinic Laboratories.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States