Milsom I, Lete I, Bjertnaes A, Rokstad K, Lindh I, Gruber C J, Birkhäuser M H, Aubeny E, Knudsen T, Bastianelli C
Department of Obstetrics and Gynaecology, Sahlgrenska Academy at Göteborg University, Göteborg, Sweden.
Hum Reprod. 2006 Sep;21(9):2304-11. doi: 10.1093/humrep/del162. Epub 2006 Jun 8.
The objective of this study was to compare cycle control, cycle-related characteristics and bodyweight effects of NuvaRing with those of a combined oral contraceptive (COC) containing 30 microg of ethinyl estradiol and 3 mg of drospirenone.
A randomized, multicentre, open-label trial in which 983 women were treated (intent-to-treat population) with NuvaRing or the COC for 13 cycles.
Breakthrough bleeding or spotting during cycles 2-13 was in general less frequent with NuvaRing than that with the COC (4.7-10.4%) and showed a statistically significant odds ratio of 0.61 (95% confidence interval: 0.46, 0.80) with longitudinal analysis. Intended bleeding was significantly better for all cycles with NuvaRing (55.2-68.5%) than that with the COC (35.6-56.6%) (P < 0.01). Changes from baseline in mean bodyweight and body composition parameters were relatively small for both groups with no notable between-group differences.
NuvaRing was associated with better cycle control than the COC, and there was no clinically relevant difference between the two groups in bodyweight.
本研究的目的是比较优思明阴道环与含30微克炔雌醇和3毫克屈螺酮的复方口服避孕药(COC)在周期控制、与周期相关的特征及体重影响方面的差异。
一项随机、多中心、开放标签试验,983名女性接受优思明阴道环或COC治疗13个周期(意向性治疗人群)。
在第2 - 13周期中,优思明阴道环突破性出血或点滴出血的总体发生率低于COC(4.7 - 10.4%),纵向分析显示统计学显著优势比为0.61(95%置信区间:0.46, 0.80)。优思明阴道环所有周期的预期出血情况(55.2 - 68.5%)显著优于COC(35.6 - 56.6%)(P < 0.01)。两组平均体重和身体成分参数相对于基线的变化较小,组间无显著差异。
与COC相比,优思明阴道环的周期控制更好,两组在体重方面无临床相关差异。