NCT06826755

Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 40 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2025-05-23
• Primary completion: 2026-09-01
• Completion: 2027-01-01
• First posted: 2025-02-14
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States