A Clinical Trial to Evaluate the Efficacy, Tolerability, and Safety of a Fixed Dose Combination of Spironolactone, Pioglitazone & Metformin (SPIOMET) in Polycystic Ovary Syndrome (PCOS)
1. On-treatment ovulation rate. (Time Frame - Following end of each two 12-week on-treatment periods (month 0-3 and month 9-12)): On-treatment ovulation rate.
2. Post-treatment ovulation rate. (Time Frame - Following the end of post-treatment period (month 12-15)): Post-treatment ovulation rate.
Secondary outcome:
1. Clinical variable: hirsutism (Time Frame - Every 3 months from study start to study completion (estimated 18 months)): Presence of hirsutism as measured by the modified Ferriman & Gallwey score
2. Clinical variable: Acne (Time Frame - Every 3 months from study start to study completion (estimated 18 months)): Presence of Acne as evaluated using the Leeds Acne Grading Scale
3. Clinical variable: menstrual regularity (Time Frame - Every 3 months from study start to study completion (estimated 18 months)): Assessment of the menstrual regularity
4. Circulating androgens (Time Frame - Every 3 months from study start to study completion (estimated 18 months)): Assessment by measurement of circulating androgens
5. Lipids (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): Assessment by measurement of total cholesterol, low-density lipoprotein (LDL-cholesterol), high-density lipoprotein (HDL- cholesterol), triglycerides;
6. Insulinaemia (Time Frame - Baseline and at the end of treatment (month 12) and 6 months after treatment): 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);
7. Inflammation markers (Time Frame - Baseline and at the end of treatment (month 12) and 6 months after treatment): Inflammation markers
8. Insulin sensitivity (Time Frame - Baseline and at the end of treatment (month 12) and 6 months after treatment): Insulin sensitivity
9. Ultra-sensitive C-reactive protein (us-CRP); (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): Ultra-sensitive C-reactive protein (us-CRP);
10. Growth-and- differentiation factor-15 (GDF15); (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): Growth-and- differentiation factor-15 (GDF15);
11. High molecular weight adiponectin (HMW-adip), (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): High molecular weight adiponectin (HMW-adip),
12. C-X-C motif chemokine ligand 14 (CXCL14) (69,81); (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): C-X-C motif chemokine ligand 14 (CXCL14) (69,81);
13. Epigenetic variable (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): Circulating microRNA 451-a (miR-451a) concentrations (88);
14. Imaging: Cardiovascular risk (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): As measured by ultrasound
15. Imaging: Body composition (Time Frame - Baseline and at the end of treatment (month 12) and 6 months after treatment): As measured by dual-energy X-ray absorptiometry (DXA)
16. Imaging: Abdominal fat distribution (subcutaneous and visceral) (Time Frame - Baseline and at the end of treatment (month 12) and 6 months after treatment): As measured by MRI
17. Imaging:hepatic fat (Time Frame - Baseline and at the end of treatment (month 12) and 6 months after treatment): As measured by MRI
18. Abdominal fat distribution (Time Frame - Baseline and at the end of treatment (month 12) and 6 months after treatment): Waist circumference, Waist to hip ratio (WHR), and hepatic fat by MRI
19. Weight (Time Frame - Every 3 months from study start to study completion (estimated 18 months)): Weight measurement
20. Improvement of co-morbidities (Time Frame - Every 3 months from study start to study completion (estimated 18 months)): Improvement of co-morbidities
21. Improvement of health behaviour (Time Frame - Every 3 months from study start to study completion (estimated 18 months)): Improvement of health behaviour
22. Improvement of health-related quality of life (HRQoL) (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): As reported by the patient
23. Safety laboratory tests (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): Blood count, electrolyte panel, urea, alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyltransferase (GGT), creatinine, vitamin B12 and folic acid;
24. Adverse events (AEs) (Time Frame - Every 3 months from study start to study completion (estimated 18 months)): As reported by the patient
25. Adherence (Time Frame - Every 3 months from study start to study completion (estimated 18 months)): Adherence will be calculated as the ratio between the number of tablets prescribed and dispensed for the period between hospital appointments and the number of tablets returned by the patient at the following appointment;
26. Acceptability of the treatment (Time Frame - Every 3 months from study start to study completion (estimated 18 months)): Acceptability of the tablet by the study patients
27. PROMs (patient-reported outcomes) (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): Questionnaire SF-36
28. PROMs (patient-reported outcomes) (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): Questionnaire PCOSQ
29. HRQoL (health-related quality of life) (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): Questionnaire SF-36
30. HRQoL (health-related quality of life) (Time Frame - Baseline, at month 3, month 6 and month 12 whiled on treatment and 6 months after the end of treatment): Questionnaire PCOSQ
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"A Clinical Trial to Evaluate the Efficacy, Tolerability, and Safety of a Fixed Dose Combination of Spironolactone, Pioglitazone & Metformin (SPIOMET) in Polycystic Ovary Syndrome (PCOS)"
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