试验摘要
潮热是更年期女性就医的最常见原因。通常使用激素替代疗法(HRT)治疗潮热。然而,并非所有女性都能使用 HRT,也不能根据需求长期使用。Researchers want to find other ways to treat hot flashes. Fezolinetant is a medicine to treat hot flashes in women going through menopause. Fezolinetant is an approved medicine in the US. Further studies are needed before it is available in other regions such as Asia.
In this study fezolinetant will be used to treat hot flashes in Japanese women going through menopause. This study will confirm the safety of fezolinetant and how well the women tolerate the treatment.
Women will either take fezolinetant or a placebo. 服用药物随机分配。安慰剂看起来像 Fezolinetant,但其中不含任何药物。The women will take 1 tablet of the study medicine (fezolinetant or the placebo) once a day for up to 52 weeks.
During the study, the women will visit their study clinic for a check-up about every 4 weeks for up to 52 weeks (1 year). 每次访视时,她们会被问及是否有任何医学问题。Other checks will include a medical examination and vital signs (temperature, blood pressure and pulse). At some visits, the women will have an ECG to check their heart rhythm and some blood and urine samples will be taken for laboratory tests. During a couple of visits, women who have a womb (uterus) will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs.
The last clinic visit will be 3 weeks after the women take their final tablet of the study medicine (fezolinetant or the placebo).
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地点
常见问题
虽然某些临床试验可能侧重于更晚期的癌症,但许多试验对处于不同癌症阶段的患者开放。每项研究都有关于参与资格的规定。例如,只有特定年龄段的患者或患有特定类型肿瘤的患者才能参与。
有时,研究人员希望参与者在临床试验期间继续接受当前治疗。有时,您可能需要暂停当前的治疗。如果研究性治疗无效,您通常可以恢复原有的治疗方案。
在癌症临床试验中,只有当该类癌症尚无其他治疗方法时,才会使用安慰剂。这有助于将研究性治疗与安慰剂进行比较。安慰剂在癌症试验中很少使用,因为通常会采用最佳可用疗法,即所谓的“标准治疗方案”。
您的医生可能并不了解所有可供您参与的临床试验机会。请与您的医生或其他医疗服务提供者讨论您所找到的临床试验信息。他们可以帮助您判断临床试验是否适合您。若您在本网站未找到任何试验选择,我们建议您访问在线公共注册网站,例如 ClinicalTrials.gov 查看各种可参与的临床试验。


