Endothelial, Autonomic and Pressure Effects of Paroxetine in Recent Postmenopause Women With Hot Flashes: a Randomized Placebo Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Endothelial function in non invasive venous occlusion plethysmography
研究概览
简要总结
Hot flashes, vasomotor symptoms that affect many postmenopausal women, are associated with cardiovascular disease and endothelial dysfunction. Estrogen therapy, associated or not with progestogens, is the standard treatment for vasomotor symptoms and improves the endothelial function of postmenopausal women with hot flushes, even those with cardiovascular risk factors, such as hypertension. It is not known whether hot flushes are a cause for the development of endothelial dysfunction or are markers of this dysfunction, evidenced by estrogen deficiency, thus representing primitive target organ (vessel) lesion. Paroxetine was approved by the FDA as a non hormonal treatment for menopausal hot flashes. In this double-blind randomized clinical trial, the vascular effects of paroxetine at a dose of 7.5 mg / day, compared to placebo, during 12 weeks are evaluated.
详细描述
Paroxetine and placebo effects at baseline and after 12 weeks in endothelial, autonomic and pressure components of vascular function are evaluated.
Non invasive venous occlusion plethysmography is used to study endothelial function; ambulatory blood pressure monitoring is used to study blood pressure variations during daytime and nocturnal descent; autonomic function is studied following sympathetic and parasympathetic parameters through heart rate variability.
The effects of paroxetine and placebo are also evaluated on:
- daytime sleepiness (through Epworth Sleepiness Scale ),
- sleep quality (through Pittsburgh Sleep Quality Index),
- perceived stress (through Perceived Scale Stress).
Biochemical and hormonal profiles including complete lipid profile, fasting glucose, insulin, estradiol, follicle stimulating hormone (FSH), luteinizing hormone (LH); inflammatory and oxidative stress markers are also studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Postmenopause
- •Present hot flushes (note ≥ 3 on a scale of 0 to 10)
排除标准
- •> 10 years of hypoestrogenism
- •Diabetes mellitus or altered fasting glycemia in use of oral hypoglycemic agents or insulin
- •BMI ≥ 35 Kg / m2
- •Uncontrolled hypertension - blood pressure (BP) ≥ 140/90 mmHg
- •Users of glucocorticoids, phytoestrogens, β-blockers, selective serotonin reuptake inhibitors (SSRIs), selective noradrenaline reuptake inhibitors (SNRIs), clonidine, gabapentin, pregabalin, cinnarizine, alphamethyldopa or any drugs with effects on the central nervous system;
- •Uncompensated hypo or hyperthyroidism;
- •Previous cardiovascular event history.
研究组 & 干预措施
Paroxetine
Paroxetine 7,5 mg - 1 pill/day for 12 weeks
干预措施: Paroxetine (Drug)
Placebo
Placebo oral capsule (corn starch) - 1 pill/day for 12 weeks
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Endothelial function in non invasive venous occlusion plethysmography
时间窗: 12 weeks
Forearm blood flow (ml/min per 100 ml)
次要结局
未报告次要终点
研究者
Ciciliana Maíla Zilio Rech
Principal Investigator
Rio de Janeiro State University