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

Completed

• Conditions: Polycystic ovary syndrome (PCOS); Nutritional, Metabolic, Endocrine; Ovarian dysfunction

• Registration Number: ISRCTN82846830
• Lead Sponsor: Vrije University Medical Centre (VUMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vascular function after metformin therapy compared to vascular function at baseline (micro and macrovascular measurements)

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures