The use of an oral contraceptive containing ethinylestradiol and drospirenone in an extended regimen over 126 days

被引:31
作者
Foidart, JM
Sulak, PJ
Schellschmidt, I [1 ]
Zimmermann, D
机构
[1] Schering AG, Global Med Dev, D-13342 Berlin, Germany
[2] Univ Liege, Dept Obstet & Gynecol, B-400 Liege, Belgium
[3] Scott & White Mem Hosp & Clin, Dept Obstet & Gynecol, Temple, TX 76508 USA
[4] Texas A&M Univ, Coll Med, Hlth Sci Ctr, Temple, TX 76508 USA
关键词
extended cycle; oral contraceptive; breakthrough bleeding; endometrial safety drospirenone;
D O I
10.1016/j.contraception.2005.06.068
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
Objective: To assess the bleeding profile, acceptance and safety of an extended 126-day regimen of the oral contraceptive Yasmin(R) [30 mu g ethinylestradiol (EE) and 3 mg drospirenone (DRSP)]. Methods: Using daily diaries, 177 women recorded bleeding events throughout the 126-day cycle. At end of treatment, the women completed questionnaires reflecting their satisfaction with the extended regimen. A Subset of 30 women underwent endometrial histology sampling after completion of the extended regimen. Results: Of 177 women assigned to the extended regimen, 80.8% completed the extended 126-day regimen. Approximately 40% of the women reported complete absence of bleeding, while in 60% a shift towards less intense bleeding was observed. The first onset of bleeding occurred after a median of 99.0 days into the extended cycle. The acceptance of the extended regimen was high, with 68.4% of the women expressing satisfaction. The general safety profile with the extended use was comparable to that seen with the conventional 21+7-day regimen. All endometrial biopsies with sufficient material for analysis were normal and supported the endometrial safety of the extended regimen. Conclusion: This study showed that the continuous use of a 30-mu g EE and 3-mg DRSP formulation over 126 days was safe, efficacious, well accepted by the users and resulted in a considerable reduction of bleeding. (C) 2006 Elsevier Inc. All rights reserved.
引用
收藏
页码:34 / 40
页数:7
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