NCT02195609已完成4 期
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.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Evaluate the changes in vasomotor symptoms.
研究概览
简要总结
This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women treated for 4 months with Omega-3 vs Soy Isoflavones.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluate the changes in vasomotor symptoms.
时间窗: 0 to 4 months
To evaluate the changes in vasomotor symptoms in postmenopausal women measured by a hot flushes self-completed diary .
次要结局
- Satisfaction with treatment(at month 1 and 4)
- General health status(months 0, 1 and 4)
- Mood status(0, 1 and 4 months)
- Rating memory status(at 0, 1 and 4 months)
- Cardiovascular risk factors(0, 1 and 4 months)
研究者
研究点 (2)
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