A multicentre, Phase III, randomised, double blind, placebo-controlled study to assess the safety and the efficacy of a weekly administered dose of 30,000 IU vitamin D (colecalciferol) in deficient patients diagnosed with PCOS

Pharma Patent Kft0 个研究点开始时间: 2016年5月11日最近更新: 2016年8月8日

研究概览

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•1.Female subject age >18 years at the time of informed consent.
•2.Clinical and/or biochemical hyperandrogenism and the proven PCOS by the Rotterdam” criteria, (ovarian dysfunction, oligo- and/or anovulation, and the morphology of polycystic ovaries on ultrasound images when other etiologies are excluded)
•3.25(OH)D levels <21ng/ml by inclusion
•4.Subject can not be under any kind of hormone or metphormine therapies and no indication that requires continuation.
•5.Has the ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study or initiation of study procedures
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 168
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Has been exposed to any investigational agent within 3 month of enrolment to the study
•2.Sever metabolic disease on endorcrine disease in etiology different from PCOS
•3.-Significant obesity (BMI> 36)
•4.Any other other signs of lab results that may lead to other etiologies in differentiation
•5.Increased serum calcium level results or symptoms of hypercalcemia in last one year
•6.Hypercalciuria or kidney stone appearance in last one year
•7.Sever kidney diseases (CKD 3 or higher)
•8.-Chronic or serious disease, which can significantly influence the absorption, metabolism of vitamin D or Ca
•9.Heart failure or angina pectoris,
•10.More than 1000 IU vitamin D per day intake or in total >3000 IU per week within 1 month prior to trial (in any forms medication, or nutritional food supplement)
•11.The patient is under hormonal therapy for the aim of ovulation stimulation or was involved in within 3 months prior the study
•12.Existence or suspected gravidity
•13.Any other finding or symptoms which are by the opinion of the Investigator may indicate a potential interference with the safety of participating trial subjects
•14.Has a known hypersensitivity to any of the investigational drug or vehicle components.
•15.Concomitant medication which is not allowed:

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