Back to resultsSoy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
Primary Purpose
Hot Flashes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
soy isoflavones
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes
Eligibility Criteria
Inclusion criteria:
- At least 5 hot flash episodes and/or night sweats per 24 hours
Exclusion Criteria:
- 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
Sites / Locations
- Brigham & Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
soy isoflavones
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01401946
First Posted
December 8, 2010
Last Updated
July 25, 2011
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01401946
Brief Title
Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
Official Title
Soy Isoflavone Tablets: Effects on Questionnaire and Actigraphic Measures of Sleep, Symptoms as Measured by the Women's Health Questionnaire and Cognitive Function as Measured by Computerized Cognitive Performance Tests in Menopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
October 2000 (Actual)
Study Completion Date
January 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study was done to elucidate relationships between midlife women's self-reported hot flashes, neuropsychological symptoms, cognitive performance or sleep.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
soy isoflavones
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
soy isoflavones
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women
Description
Hot flashes recorded by means of 5 global estimation and daily diary measures of hot flashes and night sweats.
Time Frame
Nine weeks
Title
Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women
Description
Symptoms recorded on the Women's Health Questionniare at baseline and 4 subsequent occasions
Time Frame
9 weeks
Title
Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
Description
Subjective sleep measured by average questionnaire item scores recorded each morning for a week, repeated at baseline and 4 subsequent times
Time Frame
9 weeks
Title
Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
Description
Cognitive function measured by computerized cognitive performance tests of motor speed, switching attention, continuous performance and Stroop color-word tests.
Time Frame
9 weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
At least 5 hot flash episodes and/or night sweats per 24 hours
Exclusion Criteria:
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
Facility Information:
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women
We'll reach out to this number within 24 hrs