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1月24日最近更新: 2022年5月16日

适应症

试验速览

暂无简介。

•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

•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;
•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 months of amenorrhea];
•8. Hyperprolactinaemia;
•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).

发起方

Fundació Sant Joan de Déu (FSJD)