polycystic ovary syndrome
Conditions
Interventions
Medication:
Patients will be randomised to receive metformin or placebo, two times a day 1000 mg for 6 months.
Vascular measurements:
The measurements will take place at baseline and after metformin
Sponsors
VU University Medical Center, Amsterdam, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: 1. PCOS as judged in early routine patient work-up by 3 out of the following 4 criteria: a. Oligo (mean length of the menstrual cycle > 35 days) - or amenorrhoea (based on history of oligomenorrhoea); b. Evidence of hyperandrogenism, whether clinical (hirsutism, acne, or male pattern balding) or biochemical (elevated serum androgen level [total testosterone > 2 nmol/l, and / or androstedione > 9], determined in a period while the patient was not using any medication with potential endocrine influence); c. Elevated serum LH level (³ 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 FSH level (< 10 IU/l, determined in a period while the patient was not using any medication with potential endocrine influence); d. A polycystic ovary morphology (defined by the presence of eight or more subcapsular follicular cysts ≤ 10mm and increased ovarian stroma) by ultrasound performed at our department. 2. Age: 18- 40 years; 3. One phase combined oral anticonceptives with Ê 30 ethinylestradiol (preferred are microgynon 30, stediril ‘30’, Yasmin and Diane) for at least 3 months but no other medication to avoid hormonal cyclicity and for contraceptive purposes; 4. Informed consent.
Exclusion criteria
Exclusion criteria: 1. Cardiovascular disease (hypertension (>160/90 mmHg), stroke, coronary artery disease, peripheral vascular disease, heart failure); 2. Diabetes mellitus (according to ADA criteria); 3. Hypothyroidism, hyperprolactinemia, Cushing’s syndrome nonclassical congenital adrenal hyperplasia; 4. Smoking for the last three months; 5. Alcohol use > 4U/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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vascular function after metformin therapy compared to vascular function at baseline (micro and macrovascular measurements). | — |
Contacts
Public ContactI.J.G. Ketel
VU University Medical Center, Department of Reproductive Medicine (Poli H), P.O. Box 7057
Outcome results
None listed