EUCTR2011-002203-15-IS进行中（未招募）1 期
Metformin treatment of pregnant PCOS women and prevention of late miscarriages and preterm birthThe PregMet 2 Study - PregMet 2
TNU, Norwegian University of Science and Technology0 个研究点目标入组 1,000 人开始时间: 2012年10月22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
- 1,000
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
- •Inclusion criteria
- •Age: 18-45 years
- •PCOS diagnosed or reconfirmed according to Rotterdam 2003 criteria, not more than 5 years prior to inclusion.
- •Mode of conception: Any
- •Single, viable fetus, diagnosed by vaginal ultrasound
- •Gestational week at inclusion: week 6 + 0 to 12 + 0.
- •Wash out for metformin: at least 7 days
- •Able to communicate fluently in the official language at the study cite or English
- •Informed consent
- •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 1000
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •Any type of diabetes (except GDM in former pregnancy).
- •Known liver disease or ALAT > 100 IU/L
- •Known kidney disease or creatinine > 110 µmol/L
- •Known alcohol or drug abuse
- •Use of drugs interfering with metformin: erytromycin (or other macrolides), cimetidin, anticoagulation therapy
- •Unsuitable for participation of other reasons
- •Participating in other medical trials in the same period of time
研究者
相似试验
进行中（未招募）
1 期
PregMet 2 studyPoly Cystic Ovarial Syndrome (PCOS) in pregnant women. PCOS should be diagnosed according to the Rotterdam Consensus criterias:- at least 2 out of 3 criterias1.PCO in at least one ovary2.Oligo-/anovulation (clinically diagnosed as oligo-/amenorrhea,i.e. menstrual cycles > 35 days or <10 menstruations/year3.Hyperandrogenismclinical or biochemicalMedDRA version: 14.1Level: LLTClassification code 10065161Term: Polycystic ovarian syndromeSystem Organ Class: 100000004872EUCTR2011-002203-15-SETNU, Norwegian University of Science and Technology1,000
进行中（未招募）
1 期
PregMet 2 studyPoly Cystic Ovarial Syndrome (PCOS) in pregnant women. PCOS should be diagnosed according to the Rotterdam Consensus criterias: - at least 2 out of 3 criterias 1.PCO in at least one ovary 2.Oligo-/anovulation (clinically diagnosed as oligo-/amenorrhea,i.e. menstrual cycles > 35 days or <10 menstruations/year 3.Hyperandrogenismclinical or biochemicalMedDRA version: 20.0 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome System Organ Class: 100000004872EUCTR2011-002203-15-NOTNU, Norwegian University of Science and Technology1,000
已完成
4 期
Metformin and Oral Contraceptives in PCOSPolycystic Ovary SyndromeNCT00451568Odense University Hospital90
进行中（未招募）
不适用
Metformin in pregnancy - NDEUCTR2006-003055-20-ITPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
进行中（未招募）
1 期
Metformin-Wirkung am Ovar bei PCOS (MAO-Studie) - eine PilotstudiePolycystic ovary syndrome is one of the most common endocrine disorders, affecting approximately 10% of women of reproductive age, associated with hyperandrogenaemia and menstrual dysfunction. The aim of the study is to examine the effects of the insulin sensitizing drug metformin on ovarian function and ovulation rate in women with PCOS.MedDRA version: 9.1Level: LLTClassification code 10014695Term: Endocrine disorderEUCTR2006-001911-31-ATniversitätsfrauenklinik Innsbruck20