Evaluate the Effect of Omega-3 vs Soy Isoflavones in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Open Label Study to Evaluate the Effect of (Omega-3) EPA + Docosahexaenoic Acid (DHA) vs Soy Isoflavones in 100 Postmenopausal Women Between 45-65 Years With Moderate to Severe Vasomotor Symptoms.

Conditions
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Menopause, Hot Flashes

Intervention / Treatment
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* Dietary Supplement: Omega-3
* Dietary Supplement: Soy Isoflavones


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory and can complete all study procedures, which are able to read, understand and sign an informed consent and willing to come to the center for study visits. Postmenopausal (≥ 1 year of amenorrhea) or 6 months or more of amenorrhea with follicle stimulating hormone (FSH) ≥ 40 IU / L. BMI ≥ 18 kg/m2 and ≤ 30 kg/m2 Flushing of moderate to severe intensity. Exclusion Criteria: Women with surgical menopause. Treatment with hormone replacement therapy (HRT) in the 3 months prior to inclusion Uterine bleeding after menopause with undetermined cause in the 12 months prior to screening. Presence or history of malignancy in the past 5 years. Malabsorption syndrome. Hype or uncontrolled hypothyroidism. Dyslipidemia (LDL-cholesterol> 189 mg / dl or medical criteria) requiring an specific treatment of proven effectiveness. Chronic renal disease. Uncontrolled or untreated hypertension. Treatment with isoflavones, tibolone, Selective Estrogen Receptors Moderators (SERM´s) in the past 3 months prior to the testing selection period. Hormonal treatment with androgens, estrogens, progestins, alone or combined oral, transdermal, vaginal (including promestriene) or implant, in the last 3 months prior to testing selection period. Patients who receive or require treatment with antidepressants or anticonvulsants Patients with mental illness. History of noncompliance with taking medication. Suspected or abuse of alcohol or other drugs during the 12 months preceding the selection. Use of any experimental drug or device within 30 days prior to the selection. Any other condition or finding that a judgment of the investigator may jeopardise the tral conduct according to the protocol.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Omega-3<br>600 mg (EPA, DHA and Omega-3) twice a day | Dietary Supplement: Omega-3<br>* 600 mg oral twice a day<br>* Other names: Om3gafort;|
| Other: Soy Isoflavones<br>54.4mg oral twice a day | Dietary Supplement: Soy Isoflavones<br>* 54.4 mg oral twice a day<br>* Other names: Flavia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk factors | serum cholesterol | 0 and 4 months | 
| Satisfaction with treatment | Treatment Satisfaction Questionnaire for Medication | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vasomotor Symptoms Associated With Menopause, Menopause, Hot Flashes, Postmenopausal Women