IMR Press / CEOG / Volume 43 / Issue 3 / DOI: 10.12891/ceog3223.2016

Clinical and Experimental Obstetrics & Gynecology (CEOG) is published by IMR Press from Volume 46 Issue 1 (2019). Previous articles were published by another publisher on a subscription basis, and they are hosted by IMR Press on imrpress.com as a courtesy and upon agreement with S.O.G.

Open Access Original Research
Hemostatic effects of two desogestrel-containing combined oral contraceptive regimens: a multinational, multicenter, randomized, open-label study
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1 Praxis for Gynecology, Obstetrics and Clinical Research, Hamburg (Germany)
2 Maccabi-health Service, Haifa (Israel)
3 Teva Branded Pharmaceutical Products, R&D, Inc., Frazer, PA (USA)
4 Teva Branded Pharmaceutical Products, R&D, Inc., Chester, PA (USA)
5 Teva Global Medical Affairs, Frazer PA (USA); 6 Teva Global Medical Affairs, Petach Tikva (Israel)
Clin. Exp. Obstet. Gynecol. 2016, 43(3), 334–340; https://doi.org/10.12891/ceog3223.2016
Published: 10 June 2016
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.
Keywords
Combined oral contraception
Hemostasis
Coagulation
Desogestrel
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