The effect of empagliflozin versus metformin on hormonal, metabolic and cardiovascular risk factors in patients with polycystic ovary syndrome (PCOS) – a randomised open-label parallel study. - Empagliflozin vs metformin in PCOS

Research & Development Department, Hull & East Yorkshire Hospitals NHS Trust0 个研究点目标入组 40 人开始时间: 2017年1月31日最近更新: 2018年7月23日

试验速览

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•1) Women, aged 18-45 years (inclusive), with confirmed diagnosis of PCOS based on Rotterdam criteria.
•2) Presence of both irregular periods and biochemical hyperandrogenaemia
•3) Body mass index =25
•4) Negative pregnancy test during screening visit and agree to use barrier contraception during the study period.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1) Non-classical 21-hydroxylase deficiency, hyperprolactinaemia, Cushing’s disease and androgen-secreting tumours will be excluded by appropriate tests.
•2) Any concurrent illness including type 2 diabetes.
•3) Subjects who are on any of the following medications within 3 months of recruitment:
•Metformin or other insulin-sensitizing medications (e.g., pioglitazone )
•Hormonal contraceptives (e.g., birth control pills, hormone-releasing implants, etc.)
•Anti-androgens (e.g., spironolactone, flutamide, finasteride, etc.)
•Clomiphene citrate or estrogen modulators such as letrozole
•GnRH modulators such as leuprolide
•Minoxidil
•4) Women planning to conceive.
•5) eGFR<60
•6) Hypersensitivity to lactose
•7) Severe hepatic impairment (ALT >3 times ULN)
•8) Women with history of recurrent urinary tract infections.
•9) Haematocrit above the upper limit of normal range.
•10) Have been involved in another medicinal trial (CTIMP) within the past four weeks.
•11) Known hypersensitivity to the Investigational Medicinal Products or any of their excipients.

发起方

Research & Development Department, Hull & East Yorkshire Hospitals NHS Trust