Schramm Georg, Steffens Doris
Medical Department, Grünenthal GmbH, Zieglerstrasse 6, 52078, Aachen, Germany.
Contraception. 2003 Apr;67(4):305-12. doi: 10.1016/s0010-7824(02)00536-x.
We conducted a postmarketing surveillance study to assess the long-term efficacy and tolerability of the oral contraceptive Belara (chlormadinone acetate 2.0 mg/ethinylestradiol 0.03 mg) in a normal outpatient setting. Another interest focused on changes in androgen-related skin and hair disorders.
A total of 2620 women were enrolled in a 12-cycle clinical evaluation at 435 gynecological practices throughout Germany.
An unadjusted Pearl index of 0.44 was calculated. At least 9 out of 10 pregnancies were attributable to user failure, thus resulting in an adjusted Pearl index of 0.04. More than two thirds (67.3%) of the women did not experience any bleeding disorder. Patients with intermenstrual bleeding or amenorrhea at study entry reported complete relief in 61.7% and 89.3%, respectively. Women who previously suffered from spots or bad skin showed significant improvement during the observation period (85.6%). Likewise, the percentage of patients with greasy or very greasy hair decreased markedly. The vast majority of women scored the tolerability of Belara as "very good" or "good."
The results of this postmarketing study confirm that Belara is well tolerated and provides a high contraceptive efficacy, reliable cycle stability and beneficial effects on skin and hair.
我们开展了一项上市后监测研究，以评估口服避孕药贝拉拉（醋酸氯地孕酮2.0毫克/炔雌醇0.03毫克）在普通门诊环境中的长期疗效和耐受性。另一个关注点是雄激素相关的皮肤和毛发疾病的变化。
共有2620名女性在德国各地的435家妇科诊所参加了为期12个周期的临床评估。
计算得出未调整的 Pearl 指数为0.44。每10次怀孕中至少有9次归因于使用者失误，因此调整后的 Pearl 指数为0.04。超过三分之二（67.3%）的女性未出现任何出血紊乱情况。研究开始时出现经间期出血或闭经的患者分别有61.7%和89.3%报告症状完全缓解。之前有斑点或皮肤差的女性在观察期内有显著改善（85.6%）。同样，头发油腻或非常油腻的患者比例明显下降。绝大多数女性将贝拉拉的耐受性评为“非常好”或“好”。
这项上市后研究的结果证实，贝拉拉耐受性良好，具有高避孕效果、可靠的周期稳定性以及对皮肤和毛发的有益作用。
