Print Email Facebook Twitter A prospective study on the effects on hemostasis of two oral contraceptives containing drospirenone in combination with either 30 or 20 μg ethinyl estradiol and a reference containing desogestrel and 30 μg ethinyl estradiol Title A prospective study on the effects on hemostasis of two oral contraceptives containing drospirenone in combination with either 30 or 20 μg ethinyl estradiol and a reference containing desogestrel and 30 μg ethinyl estradiol Author Kluft, C. Endrikat, J. Mulder, S.M. Gerlinger, C. Heithecker, R. TNO Kwaliteit van Leven Publication year 2006 Abstract Purpose: In this open-label, randomized study, we assessed the effects on hemostasis of two combined oral contraceptives containing drospirenone (DRSP) as progestogen component. Methods: Three milligrams of DRSP, a progestogen with antimineralocorticoid activity, was combined with either 30 or 20 μg ethinyl estradiol (EE) (DRSP/30EE; DRSP/20EE) and compared with a preparation containing 150 μg desogestrel (DSG) and 30 μg ethinyl estradiol (DSG/30EE). A total of 75 healthy female volunteers aged 18-35 years were enrolled. The hemostasis variables were measured in the medication-free precycle (baseline); in the first, third and sixth treatment cycle; and in the follow-up phase. The target variables for comparison were the relative changes from baseline to Cycle 6. Results: Data of 25 volunteers in each group were valid for the per-protocol evaluation. Most changes in hemostasis variables were similar in the three treatment groups. All procoagulatory variables and the anticoagulatory variable protein C antigen increased slightly, while protein S antigen and activity decreased. For fibrinogen and protein S activity, the changes were statistically significant: less pronounced with DRSP/20EE compared to DSG/30EE at Cycle 6. There were no statistically significant differences in the changes of antifibrinolytic variables, the global clotting tests and D-dimer. All pairwise comparisons of DRSP/30EE vs. DSG/30EE yielded nonsignificant results; however, there was a trend of a lower impact of DRSP/20EE on nearly all hemostatic parameters compared to the 30EE products. All three study treatments were safe and well tolerated by the volunteers and provided adequate contraceptive reliability. Conclusion: The changes in the hemostatic variables for DRSP/20EE were less pronounced compared to DSG/30EE and DRSP/30EE. The results were in accordance with previous reports on effects of similar OCs. © 2006 Elsevier Inc. All rights reserved. Subject BiologyBiomedical ResearchDesogestrelDose reductionDrospirenoneEthinyl estradiolHemostasisOral contraceptivesD dimerAdolescentAdultAndrostenesAntithrombinsCoagulantsContraceptives, Oral, CombinedDesogestrelEthinyl EstradiolFemaleFibrinogenFibrinolysisHomeostasisHumansProspective StudiesProtein CProtein S To reference this document use: http://resolver.tudelft.nl/uuid:13ca5001-bf9b-4638-adec-b1ea44f20017 DOI https://doi.org/10.1016/j.contraception.2005.09.015 TNO identifier 239218 ISSN 0010-7824 Source Contraception, 73 (4), 336-343 Document type article Files To receive the publication files, please send an e-mail request to TNO Library.