This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women treated for 4 months with Omega-3 vs Soy Isoflavones.
This is a non-inferiority study of Omega 3 versus Soy Isoflavones, being each patient its own control from the baseline. In order to determine the difference observed in the evolution of intensity, frequency and the total number of hot flashes in 4 months in patients treated with Omega-3 vs Soy Isoflavones, is planned to include at least 100 patients, 50 per treatment arm. It si estimated a standar deviation of 0.5%, and a 10% lost follow-up rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
75
600 mg oral twice a day
54.4 mg oral twice a day
Instituto Palacios
Madrid, Madrid, Spain
Evaluate the changes in vasomotor symptoms.
To evaluate the changes in vasomotor symptoms in postmenopausal women measured by a hot flushes self-completed diary .
Time frame: 0 to 4 months
Cardiovascular risk factors
serum cholesterol
Time frame: 0 and 4 months
Satisfaction with treatment
Treatment Satisfaction Questionnaire for Medication
Time frame: at month 1 and 4
Mood status
Hospital Anxiety and Depression Scale (HADS)
Time frame: 0, 1 and 4 months
General health status
General health status by Short-Form 36 (SF-36) questionnaire
Time frame: months 0, 1 and 4
Rating memory status
Alteration of the memory test (T@M)
Time frame: at 0, 1 and 4 months
Cardiovascular risk factors
serum triglycerides
Time frame: 0 amd 4 months
Cardiovascular risk factors
Blood pressure
Time frame: 0, 1 and 4 months
Cardiovascular risk factors
Body mass index
Time frame: 0, 1 and 4 months
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Cardiovascular risk factors
abdominal circumference
Time frame: 0, 1 and 4 months