|
ISRCTN
|
ISRCTN82846830
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Vascular function in polycystic ovary patients after treatment with metformin: its role in polycystic-ovary-syndrome-associated insulin resistance
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
NTR550
|
|
Study hypothesis
|
The specific aim in the current study is to evaluate if the use of the insulin lowering agent metformin in polycystic ovary syndrome (PCOS) has an effect on micro and macro circulation.
|
|
Lay summary
|
|
|
Ethics approval
|
Received from the local medical ethics committee
|
|
Study design
|
Randomised, double blind, placebo controlled, parallel group trial
|
|
Countries of recruitment
|
Netherlands
|
|
Disease/condition/study domain
|
Polycystic ovary syndrome (PCOS)
|
|
Participants - 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
|
|
Participants - 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)
|
|
Anticipated start date
|
01/01/2006
|
|
Anticipated end date
|
01/10/2007
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
40
|
|
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 therapy. The micro and macro circulation will be measured.
|
|
Primary outcome measure(s)
|
Vascular function after metformin therapy compared to vascular function at baseline (micro and macrovascular measurements)
|
|
Secondary outcome measure(s)
|
No secondary outcome measures
|
|
Sources of funding
|
Merck (France) - Commercial Unit CardioMetabolic Care
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
I.J.G.
Ketel
|
|
Address
|
VU University Medical Center
Department of Reproductive Medicine (Poli H)
P.O. Box 7057
|
|
City/town
|
Amsterdam
|
|
Zip/Postcode
|
1007 MB
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)20 4440041
|
|
Fax
|
+31 (0)20 4440045
|
|
Email
|
ijg.ketel@vumc.nl
|
|
Sponsor
|
Vrije University Medical Centre (VUMC) (The Netherlands)
|
|
Address
|
Van der Boechorststraat 7
|
|
City/town
|
Amsterdam
|
|
Zip/Postcode
|
1081 BT
|
|
Country
|
Netherlands
|
|
Sponsor website:
|
http://www.vumc.nl
|
|
Date applied
|
14/02/2006
|
|
Last edited
|
05/11/2008
|
|
Date ISRCTN assigned
|
14/02/2006
|
