Prevention of early cardiovascular disease in Polycystic Ovary syndrome

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 0

Inclusion Criteria

- Able to understand the written patient information and to give informed consent
- PCOS according to the Rotterdam criteria: 2 out of 3 of the following:
1. Oligo- and/or anovulation
2. Clinical and/or biochemical signs of hyperandrogenism
3. Polycystic ovary (ultrasound)
- Age =18 at screening
- Premenopausal at screening
- Negative pregnancy test
- BMI =25 at screening
- BMI<25 at screening and plasma C-peptide > 600 pmol/l
- On diet treatment for PCOS alone 1 month prior to randomisation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Actual or intended Pregnancy during the study period and 1 week after
- Hormonal contraceptives within 6 weeks prior to randomisation
- Females of childbearing potential who are not using adequate contraceptive methods according to Danish Medicines Agency’s definition. Since the use of hormonal contraception is an exclusion criterion in the study, the women should use adequate non-hormonal contraceptive methods such as cobber IUD (intra uterine device) or double barrier (simultaneous use of condom and pessary). We offer a free cobber IUD for the women included in the study.
- Nursing women
- Smoking > 10 cigarettes per day at screening
- Type 1 or 2 diabetes mellitus at screening
- Hypertension (BP >140/90) untreated, or treated hypertension at screening
- The use of medications known to influence the haemostatic-thrombotic system (as glucocorticoids inclusive inhaled preparations, BP treatment drugs)
- Use of GLP-1 receptor agonists (Exenatide, liraglutide or other) or any DPP-IV inhibitor within 3 months prior to randomisation
- Known or suspected hypersensitivity to trial product or related products
- Alcohol/drug abuse
- Cancer
- Liver disease with elevated plasma alanine aminotransferase (ALT) of more than three times the upper limit of normal (measured at visit 0 with the possibility of one repeat analysis within a week, and the last measured value as being conclusive) at screening
- Inflammatory bowel disease
- Acute or chronic pancreatitis
- MEN2
- Compromised kidney function (GFR < 60 ml/min), dialysis or kidney transplantation at screening
- Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation
- Simultaneous participation in any other clinical intervention trial