Contact information
Type
Scientific
Primary contact
Dr I.J.G. Ketel
ORCID ID
Contact details
VU University Medical Center
Department of Reproductive Medicine (Poli H)
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 4440041
ijg.ketel@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR550
Study information
Scientific title
Acronym
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.
Ethics approval
Received from the local medical ethics committee
Study design
Randomised, double blind, placebo controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Polycystic ovary syndrome (PCOS)
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Metformin
Primary outcome measures
Vascular function after metformin therapy compared to vascular function at baseline (micro and macrovascular measurements)
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/01/2006
Overall trial end date
01/10/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
40
Participant 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)
Recruitment start date
01/01/2006
Recruitment end date
01/10/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Merck (France) - Commercial Unit CardioMetabolic Care
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary