Date Modified

2019-08-30

Period

24/months

Report Summary

Recruitment completed Number assessed for eligibility 157 Number recruited and randomized 107 Final sample size 107 Trial Summary Introduction The combined oral contraceptive pill (COCP) and metformin constitute the mainstay of drug therapy for Polycystic Ovary Syndrome(PCOS). The effects of COCP and metformin on the clinical problems of PCOS remain ill understood. Objectives To determine the effects of cyproterone acetate (2mg)/ethinylestradiol (35 microg) (EE/CPA) and desogestrel 0.15mg/ethinylestradiol (20 microg) (EE/DES), alone or in combination with metformin on hirsutism, metabolic and biochemical parameters of patients with PCOS. Methodology This study was aA double-blind, randomised, parallel group study. One hundred and seven patients were randomised to receive either of four drug combinations (arm A - EE/CPA, arm B-EE/DES, arm C-EE/CPA plus metformin, arm D-EE/DES plus metformin). Inclusion criteria were PCOS diagnosed by Rotterdam Criteria 2003 and hirsutism score ?8 by modified Ferriman-Gallwey Score (mFGS). Exclusion criteria included secondary causes of hyperandrogenism. Sample size was calculated based on previous similar studies. Hirsutism was (assessed by mFGS, outer hair diameter, hair growth rate and hair density of sideburns and chin), anthropometry, blood pressure, oral glucose tolerance test, fasting insulin, HOMA-IR, HOMA–?, total testosterone, sex hormone binding globulin, leptin, free androgen index, lipid profile, visceral adiposity index, ovarian volume and patient quality of life were assessed at initiation, 6 months and 12 months of the trial. Statistical analysis was by two way ANOVA. Results Ninety nine women completed the trial and six dropped out due to adverse effects of drugs. Baseline variables were randomly distributed except age. There was no significant difference in outcomes betweem the four treatment arms at 12 months with regard to all the variables. However, there was a significant reduction in BMI, hair density and mFGS in arm A, mFGS and HOMA-? in arm B, leptin and hair density in arm C and diameter of sideburns hair in arm D at the end of 12 month. There was a significant increase in hair growth rate of chins in all four arms, total cholesterol and HDL cholesterol in arms B and D. Ovarian volume was significantly reduced and quality oflife significantly improved in all four arms. Conclusion EE/CPA and EE/DES were equally effective in improving hirsutism, hormonal and metabolic features of PCOS. Metformin did not show an additional effect. . All women were satisfied about their status of hirsutism at the end of twelve months of therapy with cyclical hormonal therapy.

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