EUCTR2013-003862-15-DK进行中（未招募）1 期
iraglutide in Polycystic Ovary SyndromeA randomised, double-blind, placebo-controlled study of the effect of Liraglutide in Polycystic ovary syndrome on risk markers of vascular Thrombosis - The LIPT-study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Jens Faber
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
- •- Able to understand the written patient information and to give informed consent
- •- PCOS according to the Rotterdam criteria: 2 out of 3 of the following:
- •1. Oligo- and/or anovulation
- •2. Clinical and/or biochemical signs of hyperandrogenism
- •3. Polycystic ovary (ultrasound)
- •- Age =18 at screening
- •- Premenopausal at screening
- •- Negative pregnancy test
- •- BMI =25 at screening
- •- BMI<25 at screening and plasma C-peptide > 600 pmol/l
- •- On diet treatment for PCOS alone 1 month prior to randomisation
- •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 70
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- Actual or intended Pregnancy during the study period and 1 week after
- •- Hormonal contraceptives within 6 weeks prior to randomisation
- •- Females of childbearing potential who are not using adequate contraceptive methods according to Danish Medicines Agency’s definition. Since the use of hormonal contraception is an exclusion criterion in the study, the women should use adequate non-hormonal contraceptive methods such as cobber IUD (intra uterine device) or double barrier (simultaneous use of condom and pessary). We offer a free cobber IUD for the women included in the study.
- •- Nursing women
- •- Smoking > 10 cigarettes per day at screening
- •- Type 1 or 2 diabetes mellitus at screening
- •- Hypertension (BP >140/90) untreated, or treated hypertension at screening
- •- The use of medications known to influence the haemostatic-thrombotic system (as glucocorticoids inclusive inhaled preparations, BP treatment drugs)
- •- Use of GLP-1 receptor agonists (Exenatide, liraglutide or other) or any DPP-IV inhibitor within 3 months prior to randomisation
- •- Known or suspected hypersensitivity to trial product or related products
- •- Alcohol/drug abuse
- •- Liver disease with elevated plasma alanine aminotransferase (ALT) of more than three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive) at screening
- •- Inflammatory bowel disease
- •- Acute or chronic pancreatitis
- •- Compromised kidney function (GFR < 60 ml/min), dialysis or kidney transplantation at screening
- •- Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- •- Simultaneous participation in any other clinical intervention trial
研究者
相似试验
进行中（未招募）
1 期
iraglutide in the treatment of polycystic ovary syndrome (LIPOS study)Polycystic ovary syndrome (PCOS).MedDRA version: 20.0 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome System Organ Class: 100000004872EUCTR2012-002073-60-GBniversity of Warwick80
尚未招募
3 期
Liraglutide and Metformin Combination on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With PCOS, Obesity and InfertilityPolycystic Ovary SyndromeInfertility, FemaleObesityNCT05952882Mỹ Đức Hospital188
已完成
不适用
The effects of Chinese herbal medicine in polycystic ovary syndrome (PCOS)ISRCTN31072075niversity of Southampton (UK)40
已完成
不适用
Inositol treatment for polycystic ovary syndrome (PCOS): Systematic review and meta-analysispolycystic ovary syndromeJPRN-UMIN000025843Yokohama University of Pharmacy100
撤回
1 期
Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment StrategyPolycystic Ovary SyndromeNCT06222437Methodist Health System85