Vascular function in polycystic ovary patients after treatment with metformin: its role in polycystic-ovary-syndrome-associated insulin resistance

Vrije University Medical Centre (VUMC) (The Netherlands)0 个研究点目标入组 40 人开始时间: 2006年2月14日最近更新: 2015年1月13日

适应症

试验速览

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•1. PCOS as judged in early routine patient work-up by three out of the following four criteria:
•1.1. Oligomenorrhoea (mean length of the menstrual cycle greater than 35 days) or amenorrhoea (based on history of oligomenorrhoea)
•1.2. Evidence of hyperandrogenism, whether clinical (hirsutism, acne, or male pattern balding) or biochemical (elevated serum androgen level [total testosterone greater than 2 nmol/l, and/or androstedione greater than 9], determined in a period while the patient was not using any medication with potential endocrine influence)
•1.3. Elevated serum leuteinising hormone (LH) level (greater than 6.5 IU/l), determined at least 2 weeks after the beginning of a menstrual period and 3 weeks before the subsequent menstrual period in the presence of a normal follicle-stimulating hormone (FSH) level (less than 10 IU/l, determined in a period while the patient was not using any medication with potential endocrine influence)
•1.4. A polycystic ovary morphology (defined by the presence of eight or more subcapsular follicular cysts less than or equal to 10 mm and increased ovarian stroma) by ultrasound performed at our department
•2. Aged 18 - 40 years
•3. One phase combined oral contraceptives with 30 ethinylestradiol (preferred are Microgynon 30®, Stediril 30, Yasmin® and Diane® 35) for at least 3 months but no other medication to avoid hormonal cyclicity and for contraceptive purposes
•4. Informed consent

•1. Cardiovascular disease (hypertension [greater than 160/90 mmHg], stroke, coronary artery disease, peripheral vascular disease, heart failure)
•2. Diabetes mellitus (according to American Diabetes Association [ADA] criteria)
•3. Hypothyroidism, hyperprolactinemia, Cushing's syndrome nonclassical congenital adrenal hyperplasia
•4. Smoking for the last three months
•5. Alcohol use greater than 4 units/day
•6. Pregnancy
•7. Diseases that influence reproductive hormone status
•8. Kidney and liver dysfunction or congestive heart failure (which can cause lactic acidosis when taking metformin)

发起方

Vrije University Medical Centre (VUMC) (The Netherlands)