1. Hemostatic effects of two desogestrel-containing combined oral contraceptive regimens: a multinational, multicenter, randomized, open-label study.
- Author
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Peters K, Gordon N, Ricciotti N, Hsieh J, Howard B, and Weiss H
- Subjects
- Adult, Antithrombins blood, Contraceptives, Oral, Combined administration & dosage, Contraceptives, Oral, Sequential administration & dosage, Desogestrel administration & dosage, Ethinyl Estradiol administration & dosage, Female, Fibrin Fibrinogen Degradation Products metabolism, Humans, Partial Thromboplastin Time, Peptide Fragments blood, Protein C metabolism, Protein S metabolism, Young Adult, Blood Coagulation drug effects, Contraceptives, Oral, Combined pharmacology, Contraceptives, Oral, Sequential pharmacology, Desogestrel pharmacology, Ethinyl Estradiol pharmacology, Fibrin Fibrinogen Degradation Products drug effects, Peptide Fragments drug effects, Protein C drug effects, Protein S drug effects, Prothrombin drug effects
- Abstract
Purpose of Investigation: To compare the effects of desogestrel (DSG) 150 mcg/ethinyl estradiol (EE) 20 mcg for 21 days followed by either seven days of EE ten mcg (21/7-active) or no treatment (DSG/EE+no Tx) on hemostatic markers., Materials and Methods: This was a randomized, multicenter, open-label study that enrolled healthy premenopausal women. Non-inferiority of 21/7-active to DSG/EE+no Tx was determined if the upper limit of the two-sided 95% CI of the mean treatment difference in prothrombin fragment 1+2 (F1+2) over 24 weeks between groups was < 130 pmol/L., Results: 246 subjects (n = 125, 21/7-active; n = 121, DSG/EE+no Tx) comprised the primary analysis. Mean F1+2 levels increased in both 21/7-active and DSG/EE+no Tx regimens (least square [LS] mean changes +45 pmol/L and +56.8 pmol/L, respectively). LS mean treatment difference was -11.8 pmol/L (95% CI: -54.8, 31.2)., Conclusion: The effect of adding EE ten mcg to the seven-day hormone-free interval of DSG/EE on F1+2 levels was non-inferior to traditional DSG/EE. more...
- Published
- 2016