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Soy Isoflavone Tablets: Effects on Sleep, Quality of Life, Symptoms and Cognitive Function in Menopausal Women

This study has been completed.
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01401946
First received: December 8, 2010
Last updated: July 25, 2011
Last verified: July 2011
History of Changes
  Purpose

The study was done to elucidate relationships between midlife women's self-reported hot flashes, neuropsychological symptoms, cognitive performance or sleep.


Condition Intervention Phase
Hot Flashes
 Drug: soy isoflavones
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Soy Isoflavone: Effects on Sleep, Symptoms, Quality of Life and Cognitive Function in Menopausal Women [ Time Frame: Nine weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    Cognitive function measured by computerized cognitive performance tests of motor speed, switching attention, continuous performance and Stroop color-word tests.


Enrollment: 88
Study Start Date: May 2000
Study Completion Date: January 2001
Primary Completion Date: October 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: soy isoflavones Drug: soy isoflavones
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401946

Locations
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Quentin R. Regestein, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT01401946     History of Changes
Other Study ID Numbers: 99-004-P
Study First Received: December 8, 2010
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013