A prospective randomized clinical study to compare the efficacy of ethinyl estradiol-drospirenone combination plus metformin versus ethinyl estradiol-drospirenone combination plus placebo on Vascular Function in Young Asian-Indian subjects with Polycystic Ovary Syndrome

All India Institute of Medical Sciences0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Females diagnosed as PCOS as per â??Rotterdam criteriaâ?? proposed by The European Society for Human Reproduction and Embryology and the American Society for Reproductive Medicineâ?? in 2003, which includes presence of two out of three criteria:
•(i) Oligo- or chronic anovulation,
•(ii) Clinical and/or biochemical signs of hyperandrogenism,
•(iii) Polycystic ovaries
•with Exclusion of other etiologies of androgen excess and
•anovulatory infertility is necessary.
•2.Willing to participate in the study after having been explained about the nature of the study
•3.Willing to return for follow up after 1, 3 and 6 months.

•1.Subject who are taking or had taken hormonal treatment last 6 months
•2.Subjects who are planning pregnancy in next 6 months or are pregnant. Urine pregnancy test will be done at screening to rule out pregnancy if required.
•3.Already diagnosed with diabetes (type 1 or 2) as per American Diabetes Association (ADA) criteria
•4.Having any systemic disease (cardiac, hepatic, endocrine or renal) or taking any kind of treatment more than one month in last six months.
•5.Diagnosed cases of malabsorption (Celiac disease, Crohnâ??s disease, Ulcerative colitis) or any history suggestive of malabsorption.
•6.Using medications known to interact with combined oral contraceptive pills (steroids, thiazide diuretics, phenytoin, phenobarbitone, and antitubercular drugs)
•7.Have known hypersensitivity to COC pills
•8.Women who had received any ovulation induction therapy such as metformin, gonadotropins or any other hormonal treatment during the preceding 6 months.
•9.Subjects who are not willing to come for follow-up

发起方