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Clinical efficacy and metabolic impact of two different dosages of ethinyl-estradiol in association with drospirenone in normal-weight women with polycystic ovary syndrome: A randomized study

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Abstract

Background: The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS). Aim: To evaluate the risk/benefit ratio of two EP combinations, containing the same progestin (3 mg drospirenone) and a different dose of ethinyl-estradiol (EE) (20 vs 30 µg) and to compare their effects on the clinical and endocrine-metabolic parameters in normal-weight PCOS women. Material/subjects and methods: In this randomized pilot study, we enrolled 30 young normal-weight PCOS women. Fifteen subjects were allocated to group A (20 µg EE) and 15 PCOS subjects to group B (30 µg EE). Hirsutism score, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinemic clamp and lipid profile were performed at baseline, and after 6 and 12 months of therapy. Main outcome measures were signs of hyperandrogenism, glucose and insulin metabolism, lipid profile. Results: Both treatment regimens induced a significant improvement in hirsutism score, testosterone, DHEAS, and SHBG levels. Androstenedione significantly dropped only in patients of Group A, while 17(OH)P only in those from Group B. Both the formulations did not significantly modify gluco-insulinemic metabolism. Total cholesterol, LDL cholesterol, and HDL cholesterol levels significantly increased in both groups. Triglycerides levels, which increased as well, resulted more markedly influenced by the formulation with 30 µg EE. Conclusions: In association with drospirenone, 20 µg EE results as effective as 30 µg in improving clinical and hormonal features of normal-weight PCOS women, while exhibiting a milder influence on lipidic parameters.

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Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, Università Cattolica del Sacro Cuore, L.go Agostino Gemelli, 8, 00168, Rome, Italy

    D. Romualdi MD, PhD, S. De Cicco, M. Busacca, D. Gagliano, A. Lanzone & M. Guido

  2. OASI Institute for Research, Troina, Italy

    A. Lanzone

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  1. D. Romualdi MD, PhD
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  2. S. De Cicco
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  3. M. Busacca
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  4. D. Gagliano
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  5. A. Lanzone
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  6. M. Guido
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Correspondence to D. Romualdi MD, PhD.

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Romualdi, D., De Cicco, S., Busacca, M. et al. Clinical efficacy and metabolic impact of two different dosages of ethinyl-estradiol in association with drospirenone in normal-weight women with polycystic ovary syndrome: A randomized study. J Endocrinol Invest 36, 636–641 (2013). https://doi.org/10.1007/BF03346756

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