EUCTR2015-004018-44-GB进行中（未招募）1 期
A Multicentre Dose-Finding, Randomised, Double-Blind, Placebo-Controlled Study to Select the Daily Oral Dose of Estetrol (E4) for the Treatment of Vasomotor Symptoms in Post-Menopausal Women - Study to select the daily dose of Estetrol for vasomotor symptoms
Donesta Bioscience0 个研究点目标入组 225 人开始时间: 2016年4月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 225
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
入选标准
- •1. Women aged 40 to 65 years, inclusive, presenting at least 7 moderate
- •to severe hot flushes/day or at least 50 moderate to severe hot flushes/week in the week preceding randomization.
- •2. Body Mass Index (BMI) between 18.0 and 35.0 kg/m², inclusive.
- •3. Post-menopausal status defined as levels of follicle stimulating
- •hormone (FSH) >40 IU/L and:
- •- amenorrhoea for at least 12 consecutive months or,
- •- amenorrhoea for at least 6 months with estradiol (E2) < 20 pg/mL or,
- •- at least 6 weeks post-surgical bilateral oophorectomy with or without
- •hysterectomy with a copy of the pathology report or a statement on
- •letterhead from the subject's physician documenting both ovaries were
- •removed is required.
- •4. For non-hysterectomised women: intact uterus with bi-layer
- •endometrial thickness = 5 mm on TVUS.
- •5. Negative pregnancy test.
- •6. Good physical and mental health, in the judgement of the Principal
- •Investigator (PI), on the basis of medical, surgical and gynaecological history, physical examination, gynaecological examination, clinical laboratory, and vital signs.
- •7. Subject has provided signed and dated written informed consent before admission to the study.
- •8. Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 225
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.For non-hysterectomised women: uterine disease or medical condition
- •including :
- •a.Bi-layer endometrial thickness >5mm as determined by TVUS;
- •b.Presence of fibroid(s) that obscure(s) evaluation of endometrium by
- •c.History or presence of uterine cancer;
- •d.Presence of endometrial hyperplasia;
- •e.Presence of an endometrial polyp with hyperplastic or malignant epithelium.
- •2.Undiagnosed vaginal bleeding in the last 12 months.
- •3.Any history of malignancy with the exception of basal cell or squamous cell carcinoma of the skin. Any clinically significant findings at the breast
- •examination and/or on mammography suspicious of breast malignancy that would require additional clinical testing to rule out breast cancer.
- •Note: A screening mammogram is required unless the subject has a written documentation of a mammogram performed within the last 9 months
- •4.Abnormal cervical Pap smear in non-hysterectomised subjects with evidence of cervical dysplasia greater than low grade squamous intraepithelial lesion.Women with a diagnosis of ASCUS may be enrolled
- •5.Systolic BP outside the range 90 to 140 mmHg, diastolic BP outside the
- •range 60 to 90 mmHg, and/or heart rate outside the range 40 to 100 bpm. Subjects with mild to moderate hypertension who are controlled on a stable antihypertension regimen may be enrolled if they meet the inclusion/exclusion criteria.
- •6.Any clinically significant abnormality identified on the screening 12-lead ECG.
- •7.History of venous or arterial thromboembolic disease (e.g., deep vein thrombosis, pulmonary embolism, stroke,myocardial infarction, angina pectoris, etc.),history of known coagulopathy or abnormal coagulation factors.
- •8.Diabetes mellitus with poor glycaemic control in the last 6 months assessed by laboratory values of glucose outside the normal ranges and glycated haemoglobin above7%.
- •9.Dyslipoproteinaemia predisposes the subject to ASCVD. If a subject has a 10 years ASCVD score = 5% as calculated using the ASCVD risk estimator, she may not be included in the trial. In all cases, LDL cholesterol level = 190 mg/dL or triglycerides plasma level > 400 mg/dL is exclusionary.
- •If a subject is receiving a lipid-lowering therapy, her treatment has to be
- •on a stable dose for at least 1 month before screening and the same eligibility criteria has to be used.
- •11.Presence or history of gallbladder disease, unless cholecystectomy has been performed
- •12.Systemic lupus erythematosus.
- •13.Multiple sclerosis.
- •14.Acute or chronic liver disease.
- •15.Acute or chronic renal impairment, including severe renal impairment.
- •16.Uncontrolled thyroid disorders.
- •17.Subject has a history of major depression or PTSD within 2 years, OR a history of other major psychiatric disorder at any time.
- •18.Use of oestrogen or progestin containing drug(s). A washout period is required before the Run-in Period in case of use of:
- •a.Vaginal hormonal products:washout of at least 4 weeks,
- •b.Transdermal oestrogen or oestrogen/progestin:washout of at least 4 weeks,
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