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
Biology
Biomedical Research
Desogestrel
Dose reduction
Drospirenone
Ethinyl estradiol
Hemostasis
Oral contraceptives
D dimer
Adolescent
Adult
Androstenes
Antithrombins
Coagulants
Contraceptives, Oral, Combined
Desogestrel
Ethinyl Estradiol
Female
Fibrinogen
Fibrinolysis
Homeostasis
Humans
Prospective Studies
Protein C
Protein 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