EUCTR2016-004386-12-DE进行中（未招募）1 期
Double-blind trial investigating the efficacy of different doses of Progesterone compared with Placebo for treatment of vasomotor symptoms - Treatment of vasomotor symptoms with oral Progesterone
Besins Healthcare Ireland Ltd.0 个研究点目标入组 304 人开始时间: 2017年5月3日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 304
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
- •Subjects eligible for inclusion in the screening period of this study must satisfy all the following criteria:
- •1.Willing and able to provide written informed consent
- •2.Adult (= 18 years), postmenopausal women, where postmenopause is defined as
- •a.at least 12 months of spontaneous amenorrhea, or
- •b.6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) levels > 40 mIU/ml, or
- •c.status at least 6 weeks after bilateral oophorectomy with or without hysterectomy, or
- •d.subject post hysterectomy without oophorectomy with documented FSH level > 40 mIU/ml and estradiol level < 20 pg/ml
- •3.Non-smoker
- •4.Mammography without pathological findings obtained within routine medical care no longer than 12 months prior to screening visit
- •5.Cervical smear (Papanicolaou test) without pathological findings (i.e. < III) obtained no longer than 12 months prior to screening visit
- •In addition subjects need to fulfil the following criterion in order to be randomized (i.e. to enter the treatment period):
- •6.A minimum of 50 moderate to severe VMS episodes over the last 7 consecutive days prior to the baseline visit, as documented in the patient diary
- •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 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 64
排除标准
- •1.Use of any hormone replacement therapy (including phytoestrogens and other plant-derived sex hormones) within 12 weeks prior to screening
- •2.Endometrial thickness = 5 mm at screening visit
- •3.Any history or current presence or suspicion of breast cancer, including carcinoma in situ and other pre-cancerous conditions
- •4.Active malignant disease of any organ system (except for localized basal cell carcinoma of the skin) or history thereof in the last 5 years prior to screening visit
- •5.Vaginal bleeding due to unidentified reason within 6 weeks prior to screening
- •6.Ongoing venous thromboembolic event or history thereof within 12 months prior to screening visit
- •7.Known severe renal insufficiency at screening visit
- •8.Known lipid metabolism disturbances of genetic origin (e.g. familial hypercholesterolemia, familial hypertriglyceridemia)
- •9.Acute or chronic liver diseases or a history of liver disease with liver enzymes having not normalized since then
- •10.Severe disturbances of hepatic function (including porphyria), hepatic tumors, also in medical history
- •11.Rotor syndrome or Dubin-Johnson syndrome
- •12.History of icterus or generalized pruritus during a previous pregnancy
- •13.History of myocardial infarction, stroke or transient ischemic attack or severe cardiac disease, including symptomatic chronic heart failure
- •14.Ongoing major depression
- •15.Use of SSRI, SNRI for any reason within 6 weeks prior to screening or planned use during the course of the study
- •16.Acupuncture for VMS within 2 weeks prior to screening or planned during the course of the study
- •17.Diabetes mellitus
- •18.Hypersensitivity to progesterone or excipients (e.g. soy) of the study medication
- •19.Medical history of HIV infection
- •20.Concomitant diseases or therapies that may cause VMS or affect VMS frequency or severity, e.g. but not limited to poorly controlled thyroid dysfunction (thyroid medication should be stable for at least 12 weeks prior to screening and TSH levels should be within range), fear disorders (e.g. panic disorders)
- •21.Participation in a clinical trial or intake of any investigational medicinal product within three months prior to screening visit
- •22.Previous participation in this clinical trial
- •23.Known or suspected drug or alcohol abuse.
研究者
相似试验
进行中（未招募）
1 期
Double-blind trial investigating the efficacy of different doses of Progesterone compared with placebo for treatment of hot flashesEUCTR2016-004386-12-ATBesins Healthcare Ireland Ltd.304
招募中
2 期
The reduction in the number of attacks in multiple sclerosis patientsMultiple sclerosisMultiple sclerosis patients.IRCT20190121042439N1Mashhad University of Medical Sciences40
尚未招募
Unknown
The effectiveness of domperidone on preventing gastric residual volume in patients admitted to the intensive care unitIRCT20220508054780N5Mashhad University of Medical Sciences60
招募中
3 期
The effect of diclofenac on pain relief after inguinal hernia surgery.Inguinal hernia.Inguinal herniaIRCT20180708040378N1Mashhad University of Medical Sciences60
进行中（未招募）
1 期
A double blind, placebo-controlled evaluation of dose realted safety and efficacy of epicutaneously applied IDEA-033 for 3 months treatment of osteoarthritis of the knee - IDEA-033 three months dose finding in OAEUCTR2004-004993-95-GBIDEA AG700