A Double-blind, Randomized, Adaptive Design, ControlledClinical Trial to Evaluate the Efficacy and Safety ofSaroglitazar 2 mg and 4 mg Tablets Versus Placebo forTreating Women with Polycystic Ovary Syndrome (PCOS)

Cadila Healthcare Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1)PCOS according to the Rotterdam criteria and falling under Phenotype A or Phenotype B.
•2)Overweight or obese patients with a BMI more than 23 kg/m2.
•3)Ability to understand and give informed consent for participation.

•1)History of anaphylaxis or known intolerance to PPAR agonist.
•2)Intake of Vitamin E ( >100 IU/day) or multivitamins containing Vitamin E ( >100
•IU/day) 3 months before enrollment.
•3)History of substance abuse within the past 12 months.
•4)Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis,
•cholestatic liver disease, Wilsons disease, hemochromatosis, etc.).
•5)In women with child bearing potential: inability or unwillingness to practice
•contraception for the duration of the study.
•6)Pregnant or breast feeding females.
•7)Women with known Cushing syndrome or hyperprolactinemia.
•8)Known late onset congenital adrenal hyperplasia, androgen-producing tumors.
•9)Refusal or inability to comply with the requirements of the protocol, for any reason,
•including scheduled clinic visits and laboratory tests.
•10)History of myopathies or evidence of active muscle diseases.
•11)History of significant cardiovascular disease (unstable angina, unstable cardiac
•dysrhythmias, uncontrolled hypertension and stroke or transient ischemic attack).
•12)History of malignancy in the past 5 years.
•13)History of bladder disease.

发起方