Gruber D, Skřivánek A, Serrani M, Lanius V, Merz M
University Clinic, General Hospital Vienna, Department of Gynecological Endocrinology and Reproductive Medicine, Vienna, Austria.
G-CENTRUM, Olomouc, Czech Republic.
Contraception. 2015 Feb;91(2):105-12. doi: 10.1016/j.contraception.2014.10.003. Epub 2014 Oct 13.
OBJECTIVE(S): To investigate the bleeding pattern and cycle control parameters of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD) compared with a patch containing 0.6 mg EE and 6 mg norelgestromin (NGMN).
In this phase III, open-label, randomized, parallel-group trial, healthy women aged 18-35 years (smokers aged 18-30 years) received either the EE/GSD patch (n=200) or the EE/NGMN patch (n=198). Treatment consisted of one patch per week for 3 weeks followed by a 7-day, patch-free interval for seven cycles. Bleeding control was assessed in two 90-day reference periods.
In reference period 1, mean number of bleeding/spotting days was comparable across treatment groups (p>0.05). However, in reference period 2, there were fewer bleeding/spotting days in the EE/GSD patch group (15.7 versus 18.4; p<0.0001). Mean number of bleeding/spotting episodes was comparable across groups for both reference periods, but bleeding/spotting episodes were shorter for the EE/GSD patch than the EE/NGMN patch during reference period 1 (5.13 days versus 5.53 days, respectively; p<0.05) and reference period 2 (5.07 versus 5.66; p=0.0001). Both treatment groups showed a similar frequency of withdrawal bleeding episodes; however, across all seven cycles, the length of these episodes was consistently shorter with the EE/GSD patch (p<0.01). There were no notable treatment differences in intracyclic bleeding.
CONCLUSION(S): Bleeding pattern and cycle control achieved with the EE/GSD patch was similar to that of the EE/NGMN patch.
The paper presents data on the bleeding pattern and cycle control parameters of an investigational transdermal contraceptive patch containing EE and GSD compared with an approved contraceptive patch containing EE and NGMN. This descriptive study found that bleeding patterns associated with the EE/GSD patch were similar to those of an EE/NGMN patch providing higher EE exposure.
研究含0.55毫克炔雌醇（EE）和2.1毫克孕二烯酮（GSD）的避孕贴片与含0.6毫克EE和6毫克诺孕酯（NGMN）的贴片相比的出血模式和周期控制参数。
在这项III期、开放标签、随机、平行组试验中，18 - 35岁的健康女性（18 - 30岁的吸烟者）接受EE/GSD贴片（n = 200）或EE/NGMN贴片（n = 198）。治疗方案为每周一片，共3周，随后是7天的无贴片间隔期，持续七个周期。在两个90天的参考期内评估出血控制情况。
在参考期1，各治疗组的出血/点滴出血天数均值相当（p>0.05）。然而，在参考期2，EE/GSD贴片组的出血/点滴出血天数较少（15.7天对18.4天；p<0.0001）。两个参考期内各治疗组的出血/点滴出血发作次数均值相当，但在参考期1（分别为5.13天对5.53天；p<0.05）和参考期2（5.07天对5.66天；p = 0.0001），EE/GSD贴片的出血/点滴出血发作持续时间比EE/NGMN贴片短。两个治疗组的撤退性出血发作频率相似；然而，在所有七个周期中，EE/GSD贴片的这些发作持续时间始终较短（p<0.01）。周期内出血方面无显著治疗差异。
EE/GSD贴片实现的出血模式和周期控制与EE/NGMN贴片相似。
本文展示了含EE和GSD的研究用透皮避孕贴片与含EE和NGMN的已批准避孕贴片相比的出血模式和周期控制参数数据。这项描述性研究发现，与EE/GSD贴片相关的出血模式与EE暴露量更高的EE/NGMN贴片相似。
