Sudhindra Mohan Bhattacharya1, Ayan Jha. 1. Department of Obstetrics and Gynaecology, SC Das Memorial Medical and Research Center, Jodhpur Park, Kolkata, India. drsudhindra54@gmail.com
Abstract
OBJECTIVE: To compare the effects of oral contraceptive pills containing desogestrel, cyproterone acetate, and drospirenone, in polycystic ovary syndrome (PCOS), after 6 and 12 months of therapy. DESIGN: Double-blind randomized controlled trial. SETTING:Gynecologic clinic of the first author. PATIENT(S): Women (n = 171) with PCOS (Androgen Excess Society criteria, 2006). INTERVENTION(S): The three-arm trial involved 58, 56, and 57 cases in desogestrel, cyproterone acetate, and drospirenone groups, respectively. Body mass index, abdominal circumference, hirsutism score (modified Ferriman Galwey), acne and acanthosis nigricans scores, and blood pressure were noted. Blood levels of total T, sex hormone-binding globulin, fasting glucose, and fasting insulin were measured. Free androgen index, glucose-insulin ratio, and homeostasis model assessment-insulin resistance were calculated. Follow-up was after 6 and 12 months of treatment. MAIN OUTCOME MEASURE(S): Primarily, absolute change in the Free Androgen Index score between the three groups and, secondarily, changes in the clinical and other hormonal and biochemical parameters were studied. RESULT(S): Six months of treatment showed similar effects. After 12 months, cyproterone acetate significantly decreased the modified Ferriman Galwey score (change = -5.29) compared with both desogestrel (change = -1.69) and drospirenone (change = -2.12); cyproterone acetate significantly increased sex hormone-binding globulin (change = 142.91) compared with desogestrel (change = 99.53); drospirenone significantly increased sex hormone-binding globulin (change = 131.52) compared with desogestrel; and cyproterone acetate significantly decreased the Free Androgen Index (change = -10.57) compared with desogestrel (change = -5.58). CONCLUSION(S): No difference in effects after 6 months. At 12 months, cyproterone acetate showed the strongest antiandrogen activities. Effects on metabolic parameters were identical. CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2010/091/000332.
RCT Entities:
OBJECTIVE: To compare the effects of oral contraceptive pills containing desogestrel, cyproterone acetate, and drospirenone, in polycystic ovary syndrome (PCOS), after 6 and 12 months of therapy. DESIGN: Double-blind randomized controlled trial. SETTING: Gynecologic clinic of the first author. PATIENT(S): Women (n = 171) with PCOS (Androgen Excess Society criteria, 2006). INTERVENTION(S): The three-arm trial involved 58, 56, and 57 cases in desogestrel, cyproterone acetate, and drospirenone groups, respectively. Body mass index, abdominal circumference, hirsutism score (modified Ferriman Galwey), acne and acanthosis nigricans scores, and blood pressure were noted. Blood levels of total T, sex hormone-binding globulin, fasting glucose, and fasting insulin were measured. Free androgen index, glucose-insulin ratio, and homeostasis model assessment-insulin resistance were calculated. Follow-up was after 6 and 12 months of treatment. MAIN OUTCOME MEASURE(S): Primarily, absolute change in the Free Androgen Index score between the three groups and, secondarily, changes in the clinical and other hormonal and biochemical parameters were studied. RESULT(S): Six months of treatment showed similar effects. After 12 months, cyproterone acetate significantly decreased the modified Ferriman Galwey score (change = -5.29) compared with both desogestrel (change = -1.69) and drospirenone (change = -2.12); cyproterone acetate significantly increased sex hormone-binding globulin (change = 142.91) compared with desogestrel (change = 99.53); drospirenone significantly increased sex hormone-binding globulin (change = 131.52) compared with desogestrel; and cyproterone acetate significantly decreased the Free Androgen Index (change = -10.57) compared with desogestrel (change = -5.58). CONCLUSION(S): No difference in effects after 6 months. At 12 months, cyproterone acetate showed the strongest antiandrogen activities. Effects on metabolic parameters were identical. CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2010/091/000332.
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