NCT02195609
Completed
Phase 4
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.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Menopause
- Sponsor
- Instituto Palacios
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Evaluate the changes in vasomotor symptoms.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Evaluate the changes in vasomotor symptoms.
Time Frame: 0 to 4 months
To evaluate the changes in vasomotor symptoms in postmenopausal women measured by a hot flushes self-completed diary .
Secondary Outcomes
- Satisfaction with treatment(at month 1 and 4)
- General health status(months 0, 1 and 4)
- Cardiovascular risk factors(0, 1 and 4 months)
- Mood status(0, 1 and 4 months)
- Rating memory status(at 0, 1 and 4 months)
Study Sites (1)
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