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Clinical and Experimental Obstetrics & Gynecology  2016, Vol. 43 Issue (3): 334-340    DOI: 10.12891/ceog3223.2016
Original Research Previous articles | Next articles
Hemostatic effects of two desogestrel-containing combined oral contraceptive regimens: a multinational, multicenter, randomized, open-label study
K. Peters1, *(), N. Gordon2, N. Ricciotti3, J. Hsieh4, B. Howard5, H. Weiss6
1Praxis for Gynecology, Obstetrics and Clinical Research, Hamburg (Germany)
2Maccabi-health Service, Haifa (Israel)
3Teva Branded Pharmaceutical Products, R&D, Inc., Frazer, PA (USA)
4Teva Branded Pharmaceutical Products, R&D, Inc., Chester, PA (USA)
5Teva Global Medical Affairs, Frazer PA (USA); 6 Teva Global Medical Affairs, Petach Tikva (Israel)
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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.
Key words:  Combined oral contraception      Hemostasis      Coagulation      Desogestrel     
Published:  10 June 2016     
*Corresponding Author(s):  K. PETERS     E-mail:  klaus@dr-peters.net

Cite this article: 

K. Peters, N. Gordon, N. Ricciotti, J. Hsieh, B. Howard, H. Weiss. Hemostatic effects of two desogestrel-containing combined oral contraceptive regimens: a multinational, multicenter, randomized, open-label study. Clinical and Experimental Obstetrics & Gynecology, 2016, 43(3): 334-340.

URL: 

https://ceog.imrpress.com/EN/10.12891/ceog3223.2016     OR     https://ceog.imrpress.com/EN/Y2016/V43/I3/334

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