EUCTR2015-004018-44-IE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. - E4 RELIEF (Response to Estetrol in Life Improvement for MEnopausal-associated hot Flushes)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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
- 性别
- Female
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:
- •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
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 TVUS;
- •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,
- •c.Oral oestrogen and/or progestin:washout of at least 4 weeks,
- •d.Intrauterine progestin therapy:washout of at least 4 weeks,
- •Current users of progestin implants or oestrogen alone injectable drug therapy are not allowed to participate unless the treatment was stopped more than 3 months ago. Current users of oestrogen pellet therapy or progestin injectable drug therapy are not allowed to participate unless
- •the treatment was stopped more than 6 months ago.
- •19.Use of non-hormonal treatments to reduce hot
研究者
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