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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Hot Flashes

Treatments: Drug: soy isoflavones; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01401946

99-004-P

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

soy isoflavones

Active Comparator group

Treatment:

Drug: soy isoflavones

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo