How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?
Key facts
- Who runs it
- Purdue University
- Where
- West Lafayette, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 240 people, planned
- Started
- 1 Mar 2025
- Planned end
- Dec 2025
- Type of study
- Interventional, 6 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- FeoSol Original Iron Supplement Tablets
- 21st Century Gelatin Capsules
- Record updated
- 13 February 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Undergoing natural perimenopause
- English-speaking
- In general good health as documented by each woman's personal report that the participant is without any past history of a chronic health condition
Who cannot take part
- Taking psychoactive drugs
- A history of hematological disorders
Where in United States
- Stone HallWest Lafayette, United StatesContact: Laura E Murray-Kolb, PhDNot yet recruiting
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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
The 6 groups in the trial
- Iron Sufficient - PlaceboPlacebo, for comparison
Women classified as iron sufficient given a 4-month supply of gelatin capsules
Treatment: 21st Century Gelatin Capsules
- Iron Sufficient - Iron SupplementsTreatment being tested
Women classified as iron sufficient given a 4-month supply of iron supplements
Treatment: FeoSol Original Iron Supplement Tablets
- Iron Deficient - PlaceboPlacebo, for comparison
Women classified as iron deficient given a 4-month supply of gelatin capsules
Treatment: 21st Century Gelatin Capsules
- Iron Deficient - Iron SupplementsTreatment being tested
Women classified as iron deficient given a 4-month supply of iron supplements
Treatment: FeoSol Original Iron Supplement Tablets
- Iron Deficient (Anemic) - PlaceboPlacebo, for comparison
Women classified as anemic given a 4-month supply of gelatin capsules
Treatment: 21st Century Gelatin Capsules
- Iron Deficient (Anemic) - Iron SupplementsTreatment being tested
Women classified as anemic given a 4-month supply of iron supplements
Treatment: FeoSol Original Iron Supplement Tablets
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Rough Journey to Menopause: How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?
- Record updated
- 13 February 2025