Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02744131
Status:
UNKNOWN
Last Update Posted:
2018-02-05
First Post:
2016-03-20
Brief Title:
OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women
Sponsor:
Kar Clinic Hospital Pvt Ltd
Organization:
Kar Clinic Hospital Pvt Ltd
Study Overview
Official Title:
OCP vs Metformin for Improvement in Clinical Symptoms and Metabolic Markers in Indian PCOS Women
Status:
UNKNOWN
Status Verified Date:
2018-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OCP
Brief Summary:
Objective To assess effectiveness of ISD Insulin sensitizing drugs Vs OCP Combined EP cyproterone acetate in improving clinical hormonal and metabolic features of PCOS polycystic ovary syndromewomen from India
Intervention
Randomized to receive Metformin 1500 mg day OR OCP EECA Life style advice to women with BMI body mass index more than 28 in both groups PS progesterone can be added for getting withdrawal bleeding for amenorrhoea of more than two months or for prolonged menstrual bleeding Study period 6 months Clinical evaluation points and tests at enrollment and again after 6 month Clinical BMI Waist circumference Hip circumference Acne score FG modified Ferriman Gallwey score after no epilation for last 6 weeks Menstrual History Biochemical Thyroid function tests ProlactinTotal Testosterone Lipid Profile FAsting blood sugar 75 gm 2 hr Glucose tolerance test GTT Sr Insulin 25- hydroxy vitamin D optional Only Radioimmunoassay Chemiluminescence assays
Acronyms OCPoral contraceptive pills PCOS polycystic ovary syndrome FBSfasting blood sugar GTTglucose tolerance test
Intervention
Randomized to receive Metformin 1500 mg day OR OCP EECA Life style advice to women with BMI body mass index more than 28 in both groups PS progesterone can be added for getting withdrawal bleeding for amenorrhoea of more than two months or for prolonged menstrual bleeding Study period 6 months Clinical evaluation points and tests at enrollment and again after 6 month Clinical BMI Waist circumference Hip circumference Acne score FG modified Ferriman Gallwey score after no epilation for last 6 weeks Menstrual History Biochemical Thyroid function tests ProlactinTotal Testosterone Lipid Profile FAsting blood sugar 75 gm 2 hr Glucose tolerance test GTT Sr Insulin 25- hydroxy vitamin D optional Only Radioimmunoassay Chemiluminescence assays
Acronyms OCPoral contraceptive pills PCOS polycystic ovary syndrome FBSfasting blood sugar GTTglucose tolerance test
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None