NCT02668185已完成2 期
Neurokinin 3 Receptor Antagonism as a Novel Treatment for Menopausal Hot Flushes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Total Number of Hot Flushes During the Final Week of Each 4 Weeks Treatment Period
研究概览
简要总结
Placebo-controlled, double-blinded, cross-over clinical trial of a new investigational product
详细描述
Double-blinded, placebo-controlled, 2-way crossover study in 30 menopausal women with untreated hot flushes treated with a neurokinin 3 receptor (NK3R) antagonist
Aims:
To investigate whether an NK3R antagonist can reduce menopausal flushing
Treatment:
4 weeks administration of active drug and placebo in random order
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 62 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Menopausal women (≥12 months since last menstrual period or bilateral oophorectomy or with a follicle stimulating hormone (FSH) level ≥20 milli-international units/millilitre (mIU/mL) and an estradiol level <190pmol/l in the absence of a reliable menstrual marker (hysterectomy with ovarian preservation or endometrial ablation)) aged 40-62 years with >7 hot flushes/day some of which are reported as severe or bothersome who have not been on treatment for menopausal symptoms for the preceding 8 weeks.
排除标准
- •Significant illness, as judged by the Investigator, within 2 weeks of first study visit.
- •Volunteer has clinical, laboratory, or electrocardiogram (ECG) evidence of uncontrolled hypertension (defined as systolic blood pressure of ≥ 160 mmHg and/or diastolic blood pressure of ≥100 mmHg); uncontrolled diabetes; or significant pulmonary, renal, hepatic, endocrine, or other systemic disease in the opinion of the Investigator.
- •Participant has a history of Gilbert's syndrome, infectious hepatitis, or other significant hepatic disease (e.g. chronic hepatitis, cirrhosis, autoimmune hepatitis, primary sclerosing cholangitis, non-alcoholic steatohepatitis, or hereditary liver disease) in the opinion of the Investigator.
- •Participant has a history of surgery which in the opinion of the investigator could cause malabsorption (e.g. gastric or small intestinal surgery or gastric bypass surgery or banding), or patient has a disease that causes malabsorption.
- •Clinically significant abnormal ECG and/or abnormalities in ECG at screening as judged by the Investigator.
- •A marked prolongation of QT/corrected QT (QTc) interval (e.g. repeated demonstration of a QTc interval > 450 ms).
- •Confirmed history of ischaemic heart disease.
- •Past (within 1 year of enrollment) or present alcohol or substance abuse
- •Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within at least 3 months of the first administration of AZD4901 in this study. The period of exclusion begins 3 months after the final dose. (Note: patients consented and screened, but not randomised in a previous study are not excluded.)
- •Participant has a history of neoplastic disease within 5 years prior to signing informed consent or is currently on ongoing treatment to prevent cancer recurrence.
- •Involvement in the planning and/or conduct of the study (applies to any AstraZeneca employee and their close relatives and/or staff at the study site directly involved in the study, regardless of their role in accordance with their internal procedures)
- •Inability to understand or cooperate with the requirements of the study
- •Participant is legally or mentally incapacitated
- •Participant has significant psychiatric disease or treatment for psychiatric disease e.g. selective serotonin re-uptake inhibitors (SSRIs) which in the opinion of the Investigator may influence the results of the study.
- •Participant has abnormal screening laboratory values as per the guidelines listed below or other clinically significant, unexplained laboratory abnormality according to the Investigator:
- •Aspartate aminotransferase (AST) >1.5 times upper limit of normal (ULN)
- •Alanine aminotransferase (ALT) > 1.5 times ULN
- •Total bilirubin >1.5 times ULN
- •Serum creatinine >2.0 times ULN
- •Clinically relevant disease and abnormalities (past or present), which in the opinion of the Investigator, may either put the patient at risk to participate in this study or may influence the results of the study or the patient's ability to participate in the study.
- •Participant has a history of hyperthyroidism or hypothyroidism or abnormal screening thyroid tests, as judged by the Investigator. Patients with hypothyroidism who are stable on treatment with normal thyroid function tests may be included in the study if in the opinion of the Investigator this will not influence the results of the study.
- •Participant has seizures, patients with history of seizures or with conditions that increase the risk of seizures.
- •Participant has a history of hypersensitivity to more than 2 chemical classes of drugs, including prescription and over-the-counter medications.
- •Participant has taken any potent or moderate CYP3A4 or CYP2C9 inhibitors, potent or moderate CYP3A4 or CYP2C9 inducers, hormonal contraceptives, antiandrogenic drugs, or other medications specified for the time frame
研究组 & 干预措施
Active drug first
Experimental
Baseline period - 2 weeks NK3R antagonist - AZD4901 - 40mg bd - 4 weeks Washout period - 2 weeks Matched placebo orally bd - 2 weeks Monitoring period - 2 weeks
干预措施: NK3R antagonist - AZD4901 (Drug)
Placebo
Placebo Comparator
Baseline period - 2 weeks Matched placebo orally bd - 2 weeks Washout period - 2 weeks NK3R antagonist - AZD4901 - 40mg bd - 4 weeks Monitoring period - 2 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Total Number of Hot Flushes During the Final Week of Each 4 Weeks Treatment Period
时间窗: Final week of each 4 week treatment period
To ensure accurate records, participants recorded their flushes in real time using either a tally chart on a piece of paper (n=34) or an application on their smartphone such as Tally Counter (Pixel Research Labs, Minneapolis-Saint Paul, MN, USA; n=3), and then collated their total number of flushes twice daily on waking to record previous overnight symptoms and before bed to record daytime symptoms.
次要结局
- Hot Flush Severity(Twice daily, morning and night for 14 weeks)
- Hot Flush Bother(twice daily (day/night) for 14 weeks)
- Hot Flush Interference(Daily at bedtime for 14 weeks)
- Skin Conductance Monitor Data.(Once per week for 48 hours over 14 weeks)
研究者
研究点 (1)
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