Melatonin Effects on Cardiovascular Disease Mechanisms in Midlife Women: A Randomized Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Maximum Age: 55
Healthy Volunteers: f
View:
• 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
Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Perimenopause Study Team
PerimenopauseStdy@mayo.edu
507-255-8897
Time Frame
Start Date: 2025-05-23
Estimated Completion Date: 2027-01
Participants
Target number of participants: 70
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic