Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
1 other identifier
interventional
88
1 country
1
Brief Summary
The study was done to elucidate relationships between midlife women's self-reported hot flashes, neuropsychological symptoms, cognitive performance or sleep.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2000
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 8, 2010
CompletedFirst Posted
Study publicly available on registry
July 26, 2011
CompletedJuly 26, 2011
July 1, 2011
5 months
December 8, 2010
July 25, 2011
Conditions
Outcome Measures
Primary Outcomes (4)
Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women
Hot flashes recorded by means of 5 global estimation and daily diary measures of hot flashes and night sweats.
Nine weeks
Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women
Symptoms recorded on the Women's Health Questionniare at baseline and 4 subsequent occasions
9 weeks
Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
Subjective sleep measured by average questionnaire item scores recorded each morning for a week, repeated at baseline and 4 subsequent times
9 weeks
Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
Cognitive function measured by computerized cognitive performance tests of motor speed, switching attention, continuous performance and Stroop color-word tests.
9 weeks
Study Arms (2)
soy isoflavones
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- At least 5 hot flash episodes and/or night sweats per 24 hours
You may not qualify if:
- Body mass index (BMI) more than 34 kg/m2
- Hypertension
- Shift work
- Psychiatric or medical conditions that would affect outcome measures
- More than 4 caffeine drinks per day
- More than 10 cigarettes per day
- More than than 7 alcohol drinks per week
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham & Women's Hospital
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 8, 2010
First Posted
July 26, 2011
Study Start
May 1, 2000
Primary Completion
October 1, 2000
Study Completion
January 1, 2001
Last Updated
July 26, 2011
Record last verified: 2011-07