Polycystic ovary syndrome (PCOS). MedDRA version: 20.0 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome System Organ Class: 100000004872
Conditions
Interventions
Trade Name: Victoza
Product Name: Liraglutide (Victoza)
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Liraglutide
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. PCOS diagnosis defined according to all three criteria of the 2003 Rotterdam Consensus Group: (i) Menstrual disorders, either amenorrhoea or less than six menses in the last 12 months; (ii) Clinical or biochemical hyperandrogenism, once secondary causes such as hyperprolactinaemia, Cushing’s syndrome, congenital adrenal hyperplasia have been excluded; (iii) Polycystic ovaries on ultrasound scan 2. Informed consent obtained before any study related activities 3. Body Mass Index (BMI) > 27 kg/m2 and BMI =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Any clinically significant disease which in the Investigator's opinion could interfere with the safety of study participants or with the results of the study 2. Diagnosis (already documented diagnosis or new diagnosis based on the OGTT results at study visit 2) of Impaired Fasting Glucose (IFG) or Impaired Glucose Tolerance (IGT) or Type 2 Diabetes Mellitus (diagnosis based on the American Diabetes Association criteria on the diagnosis and classification of diabetes mellitus) 3. Previous treatment with GLP-1 receptor agonists (including liraglutide or exenatide) or drugs that affect gastrointestinal motility or carbohydrate metabolism, or lipid-lowering or anti-obesity drugs within the last 3 months 4. Pregnancy, breast-feeding or intention to become pregnant or not using adequate contraceptive methods (adequate contraceptive measures defined as consistent use of barrier methods or true abstinence). 5. Obesity induced by other endocrinological disorders (e.g. Cushing Syndrome). The presence of other endocrinopathies will have been ruled out at the time of PCOS diagnosis. 6. Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), atypical antipsychotic, tricyclic antidepressants, and mood stabilizers (e.g., amitryptiline, imipramine, mirtazapin, phenelzine, paroxetine, thioridazine, clorpromazine, olanzapine, clozapine, lithium and valproic acid and its derivatives,) 7. Participation in a clinical trial of weight control within the last 3 months prior to screening 8. Current participation in an organised diet reduction programme (or within the last 3 months) and/or are currently using or have used within three months before screening: orlistat, pramlintide, zonisamide, topiramate (either by prescription or as part of a clinical trial) 9. Any intervention that would alter weight and therefore interfere with menstrual cyclicity, such as: (i) Diet attempts using herbal supplements or over-the-counter medications within 3 months before screening; (ii) Previous surgical treatment for obesity (excluding liposuction if performed more than one year before this study) 10. Surgery scheduled for the study duration period, except for minor surgical procedures, at the discretion of the Investigator 11. History of major depressive disorder or history of other severe psychiatric disorders, e.g. schizophrenia or bipolar disorder within the last 2 years 12. Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as TSH > 6 mIU/L or < 0.4 mIU/L, respectively 13. Impaired liver function, defined as ALAT =2.5 times upper limit of normal 14. Impaired renal function defined as serum-creatinine =110 µmol/L (= 1.3 mg/dL) or according to local label for metformin use 15. Known clinically significant active cardiovascular disease, including history of unstable angina, acute coronary event, other significant cardiac events (including history of myocardial infarction, arrhythmias, or conduction delays on electrocardiogram), or cerebral stroke within the last 6 months and/or heart failure (New York Heart Association Class III and IV) at the discretion of the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to investigate whether adding liraglutide (at a maximum dose of 1.8 mg once daily) to metformin (at a maximum dose of 1000 mg twice daily) for 52 weeks of treatment has a significant benefit in improving the regularity of periods (menstruation) in PCOS women. All PCOS women participating in the study will initially have either amenorrhoea (absence of menstrual periods in a woman of reproductive age) or less than six menses in the last 12 months (PCOS diagnosis based on the Rotterdam Consensus Group criteria), as opposed to women of reproductive age who have normal menstrual periods (9-12 menstrual periods per year with intervals of 28 to 35 days). All study participants will keep a menstrual cycle diary during the duration of the study which will be evaluated at each study visit and the primary endpoint will be assessed at the end of treatment visit, defined as improved menstrual cyclicity. Menstrual rhythm will be assessed with reference to rec ; Secondary Objective: Additional secondary outcomes will include the effects on: anthropometric measurements (e.g. body mass index); inflammatory and cardio-metabolic markers; glucose and reproductive parameters; improved quality of life. Ovulation will be also considered as a supportive secondary endpoint in the context of this study. Occurrence of ovulation (luteal serum progesterone level > 3 ng/dl) for all study participants will be assessed by progesterone determination 18-25 days following a spontaneous period. ;Primary end point(s): Improvement in menstrural cycle regularity;Timepoint(s) of evaluation of this end point: Menstrual rhythm will be assessed with reference to recording of any menstrual periods during the duration of the study (52 weeks of treatment), and PCOS women with = 6 recorded menstrual periods will be defined as having achieved improved menstrual cyclicity; this will form t | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Ovulation will be considered as a supportive secondary endpoint in the context of this study. Occurrence of ovulation (luteal serum progesterone level > 3 ng/dl) for all study participants will be assessed by progesterone determination 18-25 days following a spontaneous bleed. Additional secondary outcomes will include the effects on: anthropometric measurements (e.g. BMI); inflammatory and cardio-metabolic markers; glucose and reproductive parameters; improved quality of life. ;Timepoint(s) of evaluation of this end point: Secondary endpoints will be determined at the same time points as the primary endpoint. | — |
Countries
United Kingdom
Contacts
Public ContactDr Harpal Randeva
Warwick Medical School
Outcome results
None listed