Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
05/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vumc.nl

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

Publication citations

Additional files

Editorial Notes