To compare the efficacy of ethinyl estradiol-drospirenone oral pill with metformin against ethinyl estradiol-drospirenone oral pill with placebo on Vascular Function in Young Asian-Indian women with Polycystic Ovary Syndrome
- Conditions
- Health Condition 1: null- Subjects with Polycystic Ovarian Disease
- Registration Number
- CTRI/2013/11/004135
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 40
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of metformin on arterial stiffness and vascular function as shown by flow velocimetery in young Asian Indian subjects with Polycystic Ovarian syndrome.Timepoint: 6 months after the treatment with Intervention/Comparator Drug
- Secondary Outcome Measures
Name Time Method To study the effect of ethinyl estradiol-drospirenone combination on arterial stiffness and vascular function as shown by flow velocimetery in young asian Indian subjects with Polycystic Ovarian syndromeTimepoint: Baseline and six months