NCT02744131.
Study name | OCP vs metformin for Improvement in clinical symptoms and metabolic markers in Indian PCOS women (OCP) |
Methods | Randomised controlled trial |
Participants | Inclusion criteria ‐ Women with PCOS diagnosed by Rotterdam criteria ‐ Age > 16 or menarche of at least 2 years up to age 40. ‐ Diagnosed by Rotterdam Anovulation Ferriman‐Gallwey score ≥ 8 or Total testosterone ≥ 40 ngm/dL ovarian volume ≥ 10 cc BMI > 23 ‐ Women not attempting pregnancy at present. Exclusion criteria ‐ Women with PCOS with BMI ≤ 23 ‐ Undergoing any treatment for acne hirsutism. Including Homeopathic, Ayurvedic ‐ Known diabetic or hypertension . |
Interventions | Group a: OCP (Ethinyl Estradiol 20 mcg/ 2 mg Cyproterone acetate). Group b: MET 1500 g/day |
Outcomes | Improvements in menstrual cycle Improvement in hirsutism Improvement in acne score Weight loss following treatment Reduction in total testosterones Reduction in serum fasting insulin Improvements in lipid profile |
Starting date | 04/2016 |
Contact information | Responsible party: Sujata Kar,Odisha, India |
Notes | Recruiting |