Effects of oral and transdermal hormonal contraception on vascular risk markers: a randomized controlled trial
Department of Obstetrics and Gynecology
Administration, Cutaneous; Adolescent; Adult; Analysis of Variance; Antithrombins; Blood Coagulation; Blood Proteins; C-Reactive Protein; Contraceptives, Oral, Hormonal; Cross-Over Studies; Ethinyl Estradiol; Factor VIII; Female; Fibrinogen; Humans; Norgestrel; Oximes; Protein S; Risk Factors; Thrombosis; von Willebrand Factor
Obstetrics and Gynecology
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 alpha2macroglobulin-thrombin end point method (alpha2M-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 alpha2M-IIa (81%, 61%), and nAPCsr calibrated automated thrombinography (102%, 68%), all P
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.
DOI of Published Version
Obstet Gynecol. 2008 Feb;111(2 Pt 1):278-84. doi: 10.1097/AOG.0b013e3181626d1b. Link to article on publisher's site
Obstetrics and gynecology
Johnson JV, Lowell J, Badger GJ, Rosing J, Tchaikovski S, Cushman M. (2008). Effects of oral and transdermal hormonal contraception on vascular risk markers: a randomized controlled trial. Obstetrics and Gynecology Publications. https://doi.org/10.1097/AOG.0b013e3181626d1b. Retrieved from https://escholarship.umassmed.edu/obgyn_pp/63