A Phase II, randomised, multi-centric, multi-national clinical trial to evaluate the efficacy, tolerability, and safety of a fixed dose combination of Spironolactone, Pioglitazone & Metformin (SPIOMET) for adolescent girls and young adult women (AYAs) with polycystic ovary syndrome (PCOS).

Conditions

Polycystic ovary syndrome (PCOS)

Brief summary

On-treatment and post-treatment ovulation rate.

Detailed description

Clinical variables: weight, height, BMI, WHR, SBP, DBP, hirsutism score (modified Ferriman & Gallwey score), acne score (evaluated using the Leeds Acne Grading Scale), menstrual regularity (3,17), 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 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; HMW-adip; CXCL14(69,81);, Epigenetic variable: circulating miR-451a concentrations (88);, Imaging variables: • Cardiovascular risk – cIMT (ultrasound); • Body composition DXA; • Abdominal fat distribution (subcutaneous and visceral) and hepatic fat (MRI);, Lifestyle assessment parameters, including changes in 1): imaging variables; 2) clinical variables; 3) endocrine-metabolic variables; 4) health behaviour assessed through LIP-related self-reported Health Behaviour in School-aged Children (HBSC) questionnaire; 5) minimisation of adverse side effects and evaluation of the risk of eating disorders assessed through LIP-related questionnaires “Sick-Control-One-Fat-Food” (SCOFF) and Binge Eating Disorder Screener 7 (BEDS-7), 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;, Adherence and acceptability: • 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; • Acceptability of the tablet by the study patients;, PROMs & HRQoL: assessed through generic (SF-36) and specific (PCOSQ) questionnaires.

Related papers

No related papers found yet.

Interventions

DRUGSPIO

DRUGSPIOMET

DRUGThe current SPIOMET

DRUGPIO and Placebo formulation was defined based on the compatibility study for SPIOMET carried out by Kern Pharma (see section 2.1.P.2.2.1 of IMPD). SPIO

DRUGPIO and Placebo formulations are considered compatible. As they have the same qualitative composition as SPIOMET

DRUGthe compatibility and stability can be extrapolated from SPIOMET.

DRUGPIO

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
On-treatment and post-treatment ovulation rate.	—

Secondary

Measure	Time frame
Clinical variables: weight, height, BMI, WHR, SBP, DBP, hirsutism score (modified Ferriman & Gallwey score), acne score (evaluated using the Leeds Acne Grading Scale), menstrual regularity (3,17), 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 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; HMW-adip; CXCL14(69,81);, Epigenetic variable: circulating miR-451a concentrations (88);, Imaging variables: • Cardiovascular risk – cIMT (ultrasound); • Body composition DXA; • Abdominal fat distribution (subcutaneous and visceral) and hepatic fat (MRI);, Lifestyle assessment parameters, including changes in 1): imaging variables; 2) clinical variables	—

Measure

Time frame

Clinical variables: weight, height, BMI, WHR, SBP, DBP, hirsutism score (modified Ferriman & Gallwey score), acne score (evaluated using the Leeds Acne Grading Scale), menstrual regularity (3,17), 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 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; HMW-adip; CXCL14(69,81);, Epigenetic variable: circulating miR-451a concentrations (88);, Imaging variables: • Cardiovascular risk – cIMT (ultrasound); • Body composition DXA; • Abdominal fat distribution (subcutaneous and visceral) and hepatic fat (MRI);, Lifestyle assessment parameters, including changes in 1): imaging variables; 2) clinical variables

—

Countries

Austria, Denmark, Italy, Norway, Spain

Outcome results

None listed