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Treat Endocrinol 2003; 2 (1): 49-70 1175-6349/03/0001-0049/$30.00/0 © Adis International Limited. All rights reserved.

Ethinylestradiol/Drospirenone A Review of its Use as an Oral Contraceptive Susan J. Keam and Antona J. Wagstaff Adis International Inc., Langhorne, Pennsylvania, USA Various sections of the manuscript reviewed by: L. Bahamondes, Unidade de Reprodição Humana, Department of Obstetrics and Gynecology, School of Medicine, Universidade Estadual de Campinas (UNICAMP), Campinas, Brazil; C. Egarter, Universitätsklinik für Frauenheilkunde, Vienna, Austria; F. M. Helmerhorst, Department of Obstetrics, Gynaecology and Reproductive Medicine, Leiden University Medical Centre, Leiden, The Netherlands; F. Lüdicke, Department of Obstetrics and Gynaecology, University Hospital Geneva, Geneva, Switzerland; G. S. Merki-Feld, Clinic of Endocrinology, Department of Gynaecology and Obstetrics, University Hospital, Zurich, Switzerland; W. Oelkers, Division of Endocrinology, Department of Internal Medicine, Klinikum Benjamin Franklin, Freie University, Berlin, Germany; J. Spona, Universitätsklinik für Frauenheilkunde, Vienna, Austria. Data Selection Sources: Medical literature published in any language since 1980 on ethinylestradiol/drospirenone, identified using Medline and EMBASE, supplemented by AdisBase (a proprietary database of Adis International). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug. Search strategy: Medline search terms were ‘ethinylestradiol drospirenone’. EMBASE search terms were ‘ethinylestradiol drospirenone’ or ‘SH 470’. AdisBase search terms were ‘ethinylestradiol drospirenone’. Searches were last updated 29 October 2002. Selection: Studies in patients desiring oral contraception who received ‘ethinylestradiol drospirenone’. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included. Index terms: drospirenone, ethinylestradiol drospirenone, women, oral contraceptives, pharmacodynamics, pharmacokinetics, therapeutic use.

Contents Summary . . . . . . . . . . . . . . . . . . 1. Introduction . . . . . . . . . . . . . . . . . 2. Pharmacodynamic Profile . . . . . . . . . 2.1 Estrogenic Activity . . . . . . . . . . . 2.2 Progestogenic Activity . . . . . . . . 2.3 Antimineralocorticoid Activity . . . . 2.4 Antiandrogenic Activity . . . . . . . 2.5 Other Activity . . . . . . . . . . . . . 3. Pharmacokinetic Profile . . . . . . . . . . 3.1 Absorption and Distribution . . . . . 3.1.1 Ethinylestradiol . . . . . . . . . . 3.1.2 Drospirenone . . . . . . . . . . . 3.2 Metabolism and Elimination . . . . . 3.2.1 Ethinylestradiol . . . . . . . . . . 3.2.2 Drospirenone . . . . . . . . . . . 3.3 In Special Populations . . . . . . . . . 3.3.1 Women with Renal Impairment