Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause. Randomized Double-blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Menopause Rating Score (MRS)
研究概览
简要总结
evaluate the efficacy of paroxetine in the management of vasomotor symptoms in patients with surgical menopause, in order to seek an alternative therapy to hormone therapy, which is associated with proinflammatory and procoagulant effects that increase the risk of thrombosis and is therefore contraindicated in people with diabetes mellitus, chronic arterial hypertension and patients with a history of thromboembolism
详细描述
Vasomotor symptoms that occur in the peri-menopausal and postmenopausal period are experienced by 80% of women and can greatly affect the quality of life by temporarily interrupting daily activities. These symptoms are experienced early in our study population who are induced to early menopause by undergoing surgical procedures such as total abdominal hysterectomy plus bilateral salpingo-oophorectomy.
Due to the controversy that exists about the use of hormone replacement therapy, in recent years different alternative therapies have been proposed for the management of these symptoms, mainly for those patients who have contraindications for hormone therapy. For this reason, the use of non-hormonal therapy has been investigated.
Since there are women who have contraindications to conventional therapy such as patients with cardiovascular and thrombosis risks, there is a need to search for new alternative therapies such as selective serotonin reuptake inhibitors, specifically paroxetine, so with our study we seek to evaluate how effective paroxetine is in reducing vasomotor symptoms and thus provide an alternative to this type of patients.
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)
盲法说明
To eliminate researcher bias, a third research participant will place the capsules containing the soy isoflavonate in one bottle and the placebo in another bottle. The bottles will be labeled as group A and group B, but the researchers will not know which is in which group, to ensure that the study intervention and the control/placebo are as indistinguishable as possible to the participants.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with surgical menopause attending IHSS outpatient clinic.
- •Patients with surgical menopause with presence of hot flashes and night sweats.
- •Surgical menopausal patients with episodes of anxiety and palpitations.
- •Patients with surgical menopause who receive treatment for 6 months with Paroxetine.
- •Patients who after reading and explanation of the Informed Consent agree to participate voluntarily.
排除标准
- •Patients medicated with psychotropic drugs, including all sedatives and hypnotics.
- •Patients under treatment with Menopausal Hormone Therapy.
- •Patients with impaired hepatic or renal function.
- •Patients with unstable heart disease.
- •Patients with a history of self-destructive behaviors.
- •Patients with a history of clinical diagnosis or treatment for depression or any other psychiatric disorder (including substance abuse or alcohol disorders) and any other ongoing medical condition.
研究组 & 干预措施
Paroxetine
20mg Paroxetine once daily for 12 weeks
干预措施: Paroxetine (Drug)
Placebo
1 placebo capsule containing starch
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Menopause Rating Score (MRS)
时间窗: Since intervention until 12 weeks
change in the Menopause Rating Scale (MRS), which measures 11 variables with a score of 0 to 4, with 0 being the absence of symptoms, scores range from 0 to 44.
次要结局
- Frequency of vasomotor symptoms(Since intervention until 12 weeks)
- side effects(Since intervention until 12 weeks)
研究者
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Titular professor
Universidad Nacional Autonoma de Honduras