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OpenTrials
Completed

NCT Number: NCT01401946

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

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

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Key information

Conditions

Hot Flashes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Brigham & Women's Hospital

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soy Isoflavones

Drug

Placebo

Drug

Primary outcomes

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

    Time frame: Nine weeks

    Hot flashes recorded by means of 5 global estimation and daily diary measures of hot flashes and night sweats.

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

    Time frame: 9 weeks

    Symptoms recorded on the Women's Health Questionniare at baseline and 4 subsequent occasions

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

    Time frame: 9 weeks

    Subjective sleep measured by average questionnaire item scores recorded each morning for a week, repeated at baseline and 4 subsequent times

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

    Time frame: 9 weeks

    Cognitive function measured by computerized cognitive performance tests of motor speed, switching attention, continuous performance and Stroop color-word tests.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2000
Study completion
2001
First posted
Jul 26, 2011
Registry last updated
Jul 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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