Polycystic Ovary Syndrome (PCOS) MedDRA version: 21.1 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome System Organ Class: 100000004872
Conditions
Interventions
Product Name: SPIOMET
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Spironolactone
CAS Number: 52-01-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Fundació Sant Joan de Déu (FSJD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age range within the AYAs category (> 12.0 years and = 23.9 years at study start); 2. Gynaecological age of 2 years or more; 3. Clinical androgen excess, as defined by the presence of hirsutism (modified Ferriman-Gallwey score = 4) and/or inflammatory acne (Leeds scale) unresponsive to medications. The scarce normative data existing in adolescents suggest that an adult level of hirsutism is reached around 2 years after menarche; 4. Biochemical androgen excess, as defined by increased total testosterone (=50 ng/dL), and/or a FAI higher than 3.5 [FAI, total testosterone (nmol/L) x 100/SHBG (nmol/L)], in the follicular phase of the cycle (days 3–7) or after 2 months of amenorrhea; 5. Menstrual irregularity, as defined by = 8 menses per year corresponding to an average intermenstrual time of =45 days; 6. Written informed consent obtained from the patient, or assent from the patient and consent by the parents or the legally acceptable representative if she is a minor Are the trial subjects under 18? yes Number of subjects for this age range: 180 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 184 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Class II obesity or morbid obesity (BMI of 35 kg/m2 or higher) according to published international standard charts for both adolescents and young women; 2. Underweight (BMI200 ng/dL in the follicular phase of the cycle or after 2 months of amenorrhea]; 8. Hyperprolactinaemia (due to any cause including breast-feeding); 9. Clinical suspicion or laboratory confirmation of glucose intolerance or diabetes mellitus; 10. Use of medications affecting gonadal or adrenal function, or carbohydrate or lipid metabolism in the previous three months (including OCs); 11. Gynaecological age < 2.0 years; 12. Positive pregnancy test; 13. Pregnancy risk (failure to guarantee the use of non-hormonal contraception in sexually active subjects); 14. Cardiac failure or history of cardiac failure.; 15. Hypersensitivity to the study drugs or any of their excipients; 16. Clinical suspicion of Addison's disease; 17. Clinical suspicion of any type of acute metabolic acidosis (such asi.e., lactic acidosis, diabetic ketoacidosis); 18. Diabetic pre-coma; 20. Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock; 21. Any disorders which may cause tissue hypoxia (especially acute disease or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock; 22. Acute alcohol intoxication, Clinical suspicion of alcoholism; 23. Clinical suspicion or laboratory confirmation of Hyperkalaemia; 24. Concomitant use of eplerenone or other potassium sparing diuretics; 25. Concomitant use of other potassium- conserving diuretics and potassium supplements should not be given routinely; 26. Current bladder cancer or a history of bladder cancer; 27. Non-investigated macroscopic haematuria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the efficacy of SPIOMET in normalising ovulation in adolescents and young adult women with PCOS.;Secondary Objective: To test the efficacy of SPIOMET in normalising the endocrine-metabolic status, body composition and abdominal fat distribution, on-treatment and post-treatment; to assess the safety of SPIOMET and the adherence and subjective acceptability, and the quality of life of participating subjects.;Primary end point(s): On-treatment and post-treatment ovulation rate.;Timepoint(s) of evaluation of this end point: Following end of each two 12-week on-treatment periods (month 0-3 and month 9-12), and following the end of post-treatment period (month 12-15) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Clinical variables: weight, height, BMI, WHR, SBP, DBP, hirsutism (modified Ferriman & Gallwey score), Acne (evaluated using the Leeds Acne Grading Scale), menstrual regularity 2. Endocrine-metabolic variables: • Circulating androgens: total testosterone, SHBG, FAI, androstenedione; • Lipids - total cholesterol, LDL-cholesterol, high-density lipoprotein HDL- cholesterol, triglycerides; • Insulinaemia: fasting and 2 hours after a 75-gr oral glucose load [oral glucose tolerance test (oGTT). Estimation of insulin resistance from fasting insulin and glucose levels using the homeostasis model assessment (HOMA); • Markers of inflammation & insulin sensitivity: us-CRP); GDF15; HMWadip, CXCL14; 3. Epigenetic variable: circulating miR-451a concentrations; 4. Imaging variables: • Cardiovascular risk – cIMT (ultrasound); • Body composition: DXA; • Abdominal fat distribution (subcutaneous and visceral) and hepatic fat (MRI); 5.Lifestyle assessment parameters, including changes in 1)imaging variables; 2) clinical variables;3) endocrine-metabolic variables; 4) health behaviour assessed through LIP-related selfreported Health Behaviour in School-aged Children (HBSC)questionnaire; 5) minimisation of adverse side effects and evaluation of the risk of eating disorders assessed through LIPrelated questionnaires "Sick-Control-OneFat-Food" (SCOFF) and Binge EatingDisorder Screener 7 (BEDS-7);only in case the risk is confirmed,then,the Eating Disorder Examination Questionnaire (EDE-Q) will be used; 6) PROMs on HRQoL (SF-36, PCOSQ). 6. Safety variables: •Blood count (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelet count), electrolyte panel (sodium, potassium, chloride, calcium, phosphorus), urea, ALT, AST, GGT, creatinine, vitamin B12 and folic acid;• Report of AEs; 7. Adherence and acceptability: • Adherence will be calculated as the ratio between the number of tablets prescribed and dispensed for the period between two hospital | — |
Countries
Austria, Denmark, Italy, Norway, Spain, Turkey
Contacts
Public ContactCoordinator
Fundació Sant Joan de Déu (FSJD)
Outcome results
None listed