Clinical Trial

How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?

Study acronym: MENO
Not Yet Recruiting
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Record status
This record was last updated February 13, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to investigate how iron status and heavy bleeding during the menopausal transition affect women's cognitive function and quality of life. The main questions it aims to answer are: * What is the association between iron status, cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women? * How does iron repletion, via supplementation, affect cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women? The investigators will compare the effect of iron supplements to a placebo (gelatin capsule) to see if iron supplements could improve iron status, cognitive function, mood, quality of family relationships, and quality of life of iron-deficient and/or anemic women undergoing the menopausal transition. Each participant will: * Make 2 visits (about 2 hours each - baseline and endline) to the Clinical Research Center at Purdue * Make a very brief visit at midpoint (about 10 minutes) for a checkup * Take a daily study supplement or placebo for 4 months
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-22.
Trial Details
NCT Number NCT06798584
Lead Sponsor Purdue University
Conditions Iron Deficiency Anemia Treatment, Iron Deficiency, Iron Deficiency (Without Anemia)
Enrollment 240 participants
Start Date 2025-03-01
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-02-13