Polycystic Ovary Syndrome (PCOS), especialy signs of early cardiovascular disease in women with PCOS. MedDRA version: 14.1 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome System Organ Class: 100000004872
Conditions
Sponsors
Jens Faber
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of liraglutide 1.8 mg once daily compared to placebo on changes in thrombin generation (TGT), measured as plasma levels of endogenous thrombin potential (ETP). ;Secondary Objective: To investigate the effect of liraglutide 1.8 mg once daily compared to placebo on changes in - Plasma levels of markers of cardiovascular disease: adrenomedullin, atrial natiuretic peptid (ANP), brain natriuretic peptide (BNP), N-terminal part of brain natriuretic peptide (NT-proBNP), Copeptin, high sensitivity c-reative protein (hsCRP). - Fat content and distribution: android/gynoid fat, visceral/subcutaneous fat and liver/pancreas fat. - Insulin resistance - Degree of PCOS: menstruation cycles, degree of hyperandrogenism, morphology of the ovaries (total volume, stromal volume and follicle count), plasma levels of anti-Mullerian hormone (AMH), testosterone - Plasma levels of markers of thrombosis: Thrombin generation (peak TGT), plasminogen activator inhibitor 1(PAI-1) and von Willbrandt factor (vWF).;Primary end point(s): Changes from randomisation to end of treatment after 26 weeks of intervention in TGT (measured as ETP).;Timepoint(s) of evaluation of this end point: After 26(+/-2) weeks of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes from randomisation to end of treatment after 26 weeks of intervention in: - p-Adrenomedullin - p-ANP - p-BNP, NT-proBNP - p-Copeptin - p-hsCRP - Body composition including android and gynoid fat measured by DEXA - Visceral and subcutaneous fat measured by MR - Fat content in lever and pancreas measured by 1H MR-spectroscopy - Insulin resistance measured as HOMA-1 (plasma Insulin (mU/L) x blood glucose (mmol/L)/22,5) and HOMA-2 using plasma C-peptide instead of plasma insulin, as well as measured by the Matsuda model, which measures whole-body insulin sensitivity. - TGT (Peak) - p-PAI-1 - p-vWF - p-AMH - Menstruation cycles based on bleeding diaries - Degree of hyperandrogenism determined by the Ferriman-Gallway hirsutism scale. - Plasma levels of free and total testosterone - Total ovarian volume, stromal volume and follicle count based on 3D ultrasound and stereological calculations;Timepoint(s) of evaluation of this end point: After 26(+/-2) weeks of intervention. | — |
Countries
Denmark
Contacts
Public ContactDept. of Medicine O
Jens Faber
Outcome results
None listed