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

Hot Flashes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401946
• Other study ID #: 99-004-P
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2010
• Last updated: July 25, 2011
• Start date: May 2000
• Est. completion date: January 2001

Study information

• Verified date: July 2011
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 2001
• Est. primary completion date: October 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• soy isoflavones

• Placebo

Locations

Country	Name	City	State
United States	Brigham & Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Primary	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	No
Primary	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	No