A historical cycle control comparison of two drospirenone-containing combined oral contraceptives: ethinylestradiol 30 渭g/drospirenone 3 mg administered in a 21/7 regimen versus ethinylestradiol 20 渭g/drospirenone 3 mg administered i

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• 作者：Joachim Marr^a ; ¹ ; ^{joachim.marr@bayer.com} ; Christoph Gerlinger^b ; ¹ ; Michael Kunz^b ; ¹
• 关键词：Oral contraceptives ; Ethinylestradiol ; Drospirenone ; Cycle control ; Bleeding patterns
• 刊名：European Journal of Obstetrics and Gynecology and Reproductive Biology
• 出版年：2012
• 期刊代码：92_03012115
• 类别：med
• 出版时间：May, 2012
• 卷：162
• 期：1
• 页码：91-95
• 文件大小：415 K

摘要

Objectives

To compare the bleeding patterns and cycle control of an oral contraceptive (OC) containing ethinylestradiol (EE) 30 渭g/drospirenone (drsp) 3 mg administered in a 21/7 regimen versus a lower-dose OC containing EE 20 渭g/drsp 3 mg administered in a 24/4 regimen, using data from two identically designed studies.

Materials and methods

In the first study, 326 healthy women (18-35 years) received EE 30 渭g/drsp 3 mg in a 21/7 regimen. In the second study, 1027 healthy women (17-36 years) received EE 20 渭g/drsp 3 mg in a 24/4 regimen. Participants recorded bleeding using daily completed diaries over 13 treatment cycles.

Results

During cycles 1-12, the prevalence of scheduled withdrawal bleeding was lower with EE 20 渭g/drsp 3 mg 24/4 than with EE 30 渭g/drsp 3 mg 21/7 (82.0-91.7%versus 94.8-100.0%of women, respectively); moreover, a higher proportion of women reported a maximum intensity of light scheduled withdrawal bleeding with EE 20 渭g/drsp 3 mg 24/4 than with EE 30 渭g/drsp 3 mg 21/7 (30.9-39.0%versus 13.8-20.5%of women, respectively). In cycles 2-13, unscheduled intracyclic bleeding was reported by 7.7-13.8%of EE 20 渭g/drsp 3 mg 24/4 recipients and 3.8-7.9%of EE 30 渭g/drsp 3 mg 21/7 recipients; these were mainly single bleeding days. During reference periods 1-4, the mean number of bleeding episodes was similar between groups (3.1-3.3 episodes with EE 20 渭g/drsp 3 mg 24/4 versus 3.2 episodes with EE 30 渭g/drsp 3 mg 21/7).

Conclusions

A low-dose 24/4 regimen OC containing EE 20 渭g/drsp 3 mg is generally comparable in terms of bleeding to a higher-dose 21/7 regimen OC containing EE 30 渭g/drsp 3 mg. Between-treatment differences in bleeding intensity and unscheduled intracyclic bleeding rates were observed.