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)

Fundació Sant Joan de Déu (FSJD)0 个研究点目标入组 364 人开始时间: 2022年3月31日最近更新: 2022年4月4日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 364

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: Female

入选标准

•1. Age range within the AYAs category (> 12.0 years and < or = 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 > or = 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 (> o = 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 < or = 8 menses per year corresponding to an average intermenstrual time of > or =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

排除标准

•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 (BMI<18.5 kg/m2) and eating disorders (anorexia nervosa);
•3. Anaemia or bleeding disorder;
•4. Evidence of thyroid, liver, or kidney dysfunction; if the value for a specific variable is not within the normal range for the local lab, the assessment must be repeated. If the subsequent value is within the normal range, the patient can be included in the study. Patients diagnosed with subclinical hypothyroidism or autoimmune thyroiditis
•can also be included if the condition is treated and the lab values of thyroid variables are within the normal range for the local lab;
•5. Precocious puberty [breast development before age 8 yr and/or precocious menarche (menarche before age 10.0 yr);
•6. Cushing syndrome;
•7. Late-onset adrenal hyperplasia due to 21 hydroxylase deficiency [17-hydroxyprogesterone levels >200 ng/dL in the follicular phase of the cycle or after 2 mo of amenorrhea];
•8. Hyperprolactinaemia (due to any cause included breast-feeding);
•9. 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. Addison disease.
•17. Any type of acute metabolic acidosis (such as 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. Disease 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, alcoholism.
•23. 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.

研究者

发起方

Fundació Sant Joan de Déu (FSJD)

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