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Obstetrics & Gynecology 2008;111:278-284
© 2008 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Effects of Oral and Transdermal Hormonal Contraception on Vascular Risk Markers

A Randomized Controlled Trial

Julia V. Johnson, MD, Jane Lowell, MD, Gary J. Badger, MS, Jan Rosing, PhD, Svetlana Tchaikovski, MD and Mary Cushman, MD, MSc

From the Department of Obstetrics and Gynecology, Department of Medical Biostatistics, and the Division of Hematology Oncology, Department of Medicine, University of Vermont, Burlington, Vermont; and Department of Biochemistry, Maastricht University, Maastricht, the Netherlands.

OBJECTIVE: To compare the effects of oral and transdermal contraceptives containing similar hormone formulations on vascular risk markers.

METHODS: We conducted a randomized, investigator-blinded, crossover, clinical trial with 24 healthy women, aged 18–35 years, who received 2 months of transdermal or oral contraceptive, 2 months washout, then 2 months of the alternative medication. The transdermal contraceptive contained 0.75 mg ethinyl estradiol and 6 mg norelgestromin. The oral contraceptive contained 35 mcg ethinyl estradiol and 250 mcg norgestimate. Blood samples taken before and after each treatment were analyzed in batch for D-dimer, von Willebrand factor, factor VIII, total and free protein S, antithrombin, fibrinogen, C-reactive protein, and normalized activated protein C sensitivity ratio (nAPCsr) determined with two thrombin generation-based assays, the {alpha}2macroglobulin-thrombin end point method ({alpha}2M-IIa) and calibrated automated thrombinography. Repeated measures analysis of variance was used for analysis.

RESULTS: For both contraceptives (transdermal, oral) there were significant declines in free (19%, 11%) and total protein S (19%, 13%) and antithrombin (13%, 10%); increases in fibrinogen (8%, 10%), C-reactive protein (220%, 292%), nAPCsr {alpha}2M-IIa (81%, 61%), and nAPCsr calibrated automated thrombinography (102%, 68%), all P<.05. Transdermal contraceptives had a greater effect than oral contraceptives on free protein S (P=.07), nAPCsr {alpha}2M-IIa (P=.06), and nAPCsr calibrated automated thrombinography (P=.03).

CONCLUSION: Oral and transdermal contraception with similar hormones had similar adverse effects on vascular risk markers. This suggests that this transdermal contraceptive has at least a similar thrombosis risk as its oral counterpart.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00554632

LEVEL OF EVIDENCE: I






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