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| Name | Class |
|---|---|
| Ferrer Internacional S.A. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omega-3 | Other | 600 mg (EPA, DHA and Omega-3) twice a day |
|
| Soy Isoflavones | Other | 54.4mg oral twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 | Dietary Supplement | 600 mg oral twice a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the changes in vasomotor symptoms. | To evaluate the changes in vasomotor symptoms in postmenopausal women measured by a hot flushes self-completed diary . | 0 to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular risk factors | serum cholesterol | 0 and 4 months |
| Satisfaction with treatment | Treatment Satisfaction Questionnaire for Medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santiago Palacios, MD | President of the European Foundation Woman and Health,Past President and Honorary Member of the Spanish Menopause Society, President of the Council of Affiliated Menopause Societies (CAMS) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Palacios | Madrid | Madrid | 28009 | Spain |
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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| Soy Isoflavones | Dietary Supplement | 54.4 mg oral twice a day |
|
|
| at month 1 and 4 |
| Mood status | Hospital Anxiety and Depression Scale (HADS) | 0, 1 and 4 months |
| General health status | General health status by Short-Form 36 (SF-36) questionnaire | months 0, 1 and 4 |
| Rating memory status | Alteration of the memory test (T@M) | at 0, 1 and 4 months |
| Cardiovascular risk factors | serum triglycerides | 0 amd 4 months |
| Cardiovascular risk factors | Blood pressure | 0, 1 and 4 months |
| Cardiovascular risk factors | Body mass index | 0, 1 and 4 months |
| Cardiovascular risk factors | abdominal circumference | 0, 1 and 4 months |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |