Health Condition 1: null- Subjects with Polycystic Ovarian Disease
Conditions
Interventions
Intervention1: Metformin: In the proposed study, we are planning to investigate the efficacy of metformin and ethinyl estradiol-drospirenone on cardiovascular risk factor (aortic pulse wave velocity a
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Garima Kachhawa
AIIMS
Outcome results
None listed