EUCTR2007-001791-36-DE进行中（未招募）不适用
A double-blind, randomized, placebo and active controlled, multicenter study to investigate efficacy and safety after oral administration of 2 and3 mg ZK 283197, 1 mg 17ß-estradiol and placebo once daily for 8 weeks in postmenopausal women with hot flushes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 118
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Women with at least 35 moderate to severe hot flushes in seven consecutive days during the 2-week run-in phase
- •Age: 45 – 65 years (inclusive)
- •Body mass index (BMI) : 20 - 30 kg/m² (inclusive)
- •Signed informed consent prior to study participation
- •Postmenopausal status, revealed by last spontaneous bleeding at least 12 months prior to enrollment or 6 months spontaneous amenorrhea with serum FSH levels ? 40 mIU/ml or bilateral oophorectomy (without hysterectomy) at least six weeks prior to enrollment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical and surgical history
- •Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, excretion and effect of the study drugs will not be normal
- •Previous diagnosis of cancer of any type as well as benign tumors of the liver and pituitary, including after treatment or suspicion thereof
- •Known or suspected liver disorders
- •History of thrombophlebitis, venous / arterial thromboembolic diseases (particularly deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, cerebrovascular accident, ischemic heart disease)
- •Other conditions that increase susceptibility to thromboembolic diseases (e.g. known disturbance of the coagulation system, thromboembolic diseases in close relatives at young age)
- •Migraine accompanied by disturbances in sensory perception and / or locomotion (migraine accompagnée)
- •Diabetes mellitus with vascular involvement
- •Severe hypertriglyceridemia
- •Known sensitivity to the study drugs or components of the preparations
- •Abnormal, clinically significant findings which, according to the assessment of the investigator, may worsen under hormonal treatment
- •Medication and drug use
- •Hormonal therapy (estrogen mono-therapy or combined hormone therapy, i.e. including progestin, oral, transdermal) or intrauterine hormone releasing device within 4 weeks prior to study entry or any long-acting injectable or implant up to 6 months before study entry, or any other therapy of menopausal symptoms, e.g. plant-based products within 4 weeks prior to study entry
- •Intake of an investigational compound within 8 weeks before study screening
- •Concomitant repeated medication with drugs which could affect the study aim under consideration of their elimination and/or the duration of their influencing effects on the study drug:
- •Drugs which might affect absorption (e.g. laxatives, loperamide, metoclopramide, antacids, H2-receptor antagonists)
- •Anticoagulants (e.g. heparin, coumarin)
- •Antiepileptics (hydantoin derivates e.g. phenytoin, or carboxamid derivates e.g. carbamazepin, oxcarbamazepin, other antiepileptics e.g. Felbamat, Topiramate)
- •Hypnotica and sedativa (barbiturate derivates e.g. phenobarbital, primidone)
- •Tuberculostatics (e.g. rifampicin)
- •Oral antimycotics (e.g. griseofulvin, ketoconazol, itraconazol, fluoconazol)
- •Virostatic agents (systemic, e.g. oral, or genital administration, e.g. ritonavir)
- •Selective estrogen receptor modulators (e.g. raloxifene, tamoxifen)
- •Products containing St. John’s wort, grapefruit juice
- •Continuous systemic use of antibiotics for >14 days
- •Corticosteroids (systemic, e.g. oral, or genital administration)
- •Suspicion of drug or alcohol abuse (within the last 2 years)
- •Special behavioral patterns
- •Smoking (former smokers who have stopped smoking at least 3 months before study drug administration may be included)
- •Electrocardiogram (ECG), blood pressure, heart rate
- •Clinically relevant ECG findings
- •Systolic blood pressure > 160 mmHg (after at least 3 min in supine position)
- •Diastolic blood pressure > 95 mmHg (after at least 3 min in supine position)
- •Heart rate < 45 or > 100 beats/min (after at least 3 min in supine position)
- •Physical examination
- •Clinically relevant findings in the physical examination (e.g. pronounced varicosis, thrombophlebitis, evidence of peripheral circulatory disturbances)
- •Mammography
- •Suspicious structures in mammography (to be performed within the last 9 months before screening) that may indicate a malignant t
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