EUCTR2007-001791-36-GBActive, not recruitingPhase 1
A double-blind, randomized, placebo and active controlled, multicenter study to investigate efficacy and safety after oral administration of 2 and 3 mg ZK 283197, 1 mg 17ß-estradiol and placebo once daily for 8 weeks in postmenopausal women with hot flushes
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Bayer Schering Pharma AG
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •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
Exclusion Criteria
- •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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