EUCTR2004-000053-34-CZ进行中（未招募）不适用
Comparison of continuous combined estrogen-progestin regimen in alleviation of estrogen deficiency symptoms of postmenopausal women. A randomized, double-blind, fixed dose, multicentre phase IIIb study of 12 month
Orion Corporation, Orion Pharma, Orionintie,0 个研究点目标入组 675 人开始时间: 2004年10月11日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 675
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
- •signed and dated IC
- •Postmenopausal women: = 12 months of spontaneous amenorrhoea or = 6 weeks post-surgical bilateral oophorectomy without hysterectomy at screening
- •= 30 moderate to severe hot flushes per week at baseline and/or vasomotor symptoms requiring treatment according to clinical judgement of the investigator
- •Wash-out period
- •-is not needed or
- •-of 1 wk or longer for prior vaginal hormonal products (rings, creams, gels)
- •-of 4 wks or longer for prior transdermal estrogen alone or estrogen/progestin products
- •-of 4 wks or longer for prior oral estrogen and/or estrogen/progestin therapy
- •-of 8 wks or longer for prior intrauterine progestin therapy
- •-of 3 months or longer for prior progestin implants and estrogen alone injectable drug therapy
- •-of 6 months or longer for prior estrogen pellet therapy or progestin injectable drug therapy
- •no pathological findings in mammogram obtained within 6 months of screening visit
- •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
- •36 months of spontaneous amenorrhea at screening
- •pregnancy or breastfeeding
- •known or past endometrial hyperplasia or cancer
- •known, past, or suspected estrogen-dependent malignant tumours (e.g. breast cancer)
- •cervical smear class III-IV according to the Bethesda classification
- •undiagnosed uterine bleedings
- •previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism)
- •active or recent arterial thromboembolic disease (e.g. angina pectoris, myocardial infarction)
- •personal or strong family history of thromboembolism or recurrent (= 3) spontaneous abortions
- •heart failure (NYHA class III-IV)
- •cerebrovascular accidents, stroke or transient ischemic attacks in the subject history
- •serious disorders of blood coagulation system
- •acute liver disease or a history of liver disease (including cholelithiasis) with clinically significant abnormalities in liver function tests at baseline
- •uterine fibroids
- •endometriosis
- •known hypersensitivity to any component of the preparations
- •uncontrolled or poorly controlled hypertension (diastolic BP > 95 mmHg and/or systolic BP > 160 mmHg) despite of antihypertensive treatment
- •severe or uncontrolled thyroid disease, e.g. thyreotoxicosis
- •impaired renal function with clinically significant elevated serum creatinine concentration
- •insulin-dependent diabetes mellitus
- •diagnosed psychiatric disorders (e.g. schizophrenia, depression)
- •systemic lupus erythematosus (SLE)
- •any other treatment for climacteric symptoms
- •any treatment for hyperlipidemias
- •any treatment affecting sex hormone system (e.g. phytoestrogens like soya)
- •suspected alcohol or drug abuse
- •suspected poor compliance
- •participation in another clinical study within the previous 60 days or during the study
- •clinically significant abnormalities in the laboratory assessments at baseline
研究者
相似试验
招募中
3 期
Comparison of the effects of conjugated estrogen with vaginal sildenafil on endometrial diameterInfluence of different factors on endometrial thickness.IRCT20220314054278N1Oroumia University of Medical Sciences30
已完成
不适用
The effect of continuous combined oestrogen and progesterone arterial compliance, left ventricular function and cognition in elderly womeHormone replacement therapy (HRT)Urological and Genital DiseasesISRCTN38837264Department of Health (UK)
招募中
不适用
A clinical trial to study the effects of estradiol as compared to EMLA cream on pain due to puncturing the vein and easiness during inserting cannula in obese female patients.CTRI/2014/11/005162A132
招募中
2 期
Comparison of two different Estrogen doses in prevention of synechia after hysteroscopic treatment of Asherman syndrom patientsAsherman syndrome.Intrauterine synechiaeIRCT20141230020486N3Mashhad University of Medical Sciences60
招募中
不适用
Progestin-only and Combined Estrogen-Progestin Contraceptive Pills after Surgery of Ovarian Endometrioma: A Randomized Controlled StudyEndometriotic cystEndometriosis,Ovarian cystTCTR20180725001Faculty of Medicine, Ramathibodi Hospital136