Effects of oral and transdermal hormonal contraception on vascular risk markers - A randomized controlled trial
ABSTRACT To compare the effects of oral and transdermal contraceptives containing similar hormone formulations on vascular risk markers.
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.
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<.05. Transdermal contraceptives had a greater effect than oral contraceptives on free protein S (P=.07), nAPCsr alpha2M-IIa (P=.06), and nAPCsr calibrated automated thrombinography (P=.03).
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.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00554632
- SourceAvailable from: Hanna Zielinska-Blizniewska
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- "Podczas przyjmowania antykoncepcji doustnej prawidłowy poziom niemal wszystkich białek układu krzepnięcia zostaje zaburzony. Nawet nieduże odstępstwo od normy jednego białka układu krzepnięcia zaburza delikatną równowagę i może powodować uruchomienie całej kaskady układu krzepnięcia i fibrynolizy     . Janczewski i wsp. "
ABSTRACT: IntroductionThe aim of the study was to evaluate the correlation between hormonal contraceptives and sex hormones levels as a possible cause of vertigo related to coagulation disorders and fibrinolyse.Material and methodsThe study was conducted on 25 female patients aged 23–39, who were treated at the Department of Otolaryngology and Laryngological Oncology, Medical University of Lodz, due to vertigo. The studied patients were divided into 3 groups: I – 7 women that used hormonal contraceptives; II – 9 women that no used hormonal contraceptives for the last 6 months; III – 9 women who never used contraceptives. The methodology included: an otoneurological and audiological examination, blood tests, levels of fibrinogen, D-dimers, APTT, PT, ALAT, ASPAT and BMI, estradiol and progesterone levels.ResultsIn 16 out of the 25 patients the obtained results diverged from normal sex hormones concentration in serum. In each studied group the relation between sex hormones concentration in serum and coagulation and fibrinolyse parameters was proved. The correlation between an increased concentration progesterone and D-dimers was found.Conclusions An increased concentration of estrogens in serum may have an additional negative effect on a possibility of a thromboembolic episode. In the female patients interested in oral contraception, the prophylactic exclusion of risk factors for a thromboembolic disease seems to be vital.Otolaryngologia polska. The Polish otolaryngology 01/2013; 67(1):25–29. DOI:10.1016/j.otpol.2012.09.008
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