Christie T
Wyeth-Ayerst International Inc., Philadelphia, Pennsylvania.
Int J Fertil. 1989 Sep;34 Suppl:40-9.
In three ongoing open studies conducted by 50 investigators in Europe, South America, and New Zealand, 639 subjects followed a new triphasic regimen of gestodene (GTD) and ethinyl estradiol (EE) for 3,020 cycles. One study used GTD + EE only, but in each of the other two studies a comparator oral contraceptive (OC) also was given: norethisterone (NET) + EE in one and desogestrel (DSG) + EE in the other. The objective of all three studies was to assess the efficacy, cycle control, and safety of the triphasic GTD + EE. The following is a report of the interim results. Statistical analysis was performed only on differences between groups in the incidences of bleeding irregularities. During six treatment cycles, subjects either followed the GTD + EE regimen (50 micrograms GTD + 30 micrograms EE for 6 days, 70 micrograms GTD + 40 micrograms EE for 5 days, and 100 micrograms GTD + 30 micrograms EE for 10 days) or took triphasic NET + EE or monophasic DSG + EE. Each cycle concluded with a seven-day hiatus in study medication. No pregnancies occurred with any of the contraceptive preparations (Pearl Index = 0). Compliance was good in all studies and a majority of subjects were still participants at cycle 6. Normal bleeding was reported during 92% of the total evaluable cycles of GTD + EE use. Cycle control with GTD + EE was superior to that with NET + EE or DSG + EE: Breakthrough bleeding occurred in 1.5% of the pooled GTD + EE cycles versus 6.6% of the NET + EE cycles and 2.6% of the DSG + EE cycles; spotting occurred in 4.5% of the GTD + EE cycles versus 9.7% of the NET + EE cycles and 10.3% of the DSG + EE cycles; and breakthrough bleeding plus spotting occurred in 2.1% of the GTD + EE cycles versus 8.1% of the NET + EE cycles and 4.6% of the DSG + EE cycles. Amenorrhea occurred in 2.0% of the cycles with NET + EE, but was reported by only 0.3% of all the subjects given GTD + EE and 0.7% of those given DSG + EE. Cycle length and intensity of bleeding changed little during the use of any of the study preparations. Mean length of withdrawal bleeding during the GTD + EE regimen shortened from 4.5 days (prestudy) to 4.0 days. With each OC, the subjects' mean weight during cycles 3 and 6 differed less than 0.5 kg from baseline values.(ABSTRACT TRUNCATED AT 400 WORDS)
在欧洲、南美洲和新西兰由50名研究人员进行的三项正在进行的开放性研究中，639名受试者采用了孕二烯酮（GTD）和炔雌醇（EE）的新三相方案，共进行了3020个周期。一项研究仅使用GTD + EE，但在其他两项研究中，还分别给予了对照口服避孕药（OC）：一项给予炔诺酮（NET）+ EE，另一项给予去氧孕烯（DSG）+ EE。所有三项研究的目的都是评估三相GTD + EE的疗效、周期控制和安全性。以下是中期结果报告。仅对各组间出血异常发生率的差异进行了统计分析。在六个治疗周期中，受试者要么遵循GTD + EE方案（50微克GTD + 30微克EE，共6天；70微克GTD + 40微克EE，共5天；100微克GTD + 30微克EE，共10天），要么服用三相NET + EE或单相DSG + EE。每个周期结束时，研究药物有七天的停药期。任何一种避孕制剂均未发生妊娠（Pearl指数 = 0）。所有研究中的依从性都很好，大多数受试者在第6周期时仍在参与研究。在使用GTD + EE的所有可评估周期中，92%报告为正常出血。GTD + EE的周期控制优于NET + EE或DSG + EE：在汇总的GTD + EE周期中，突破性出血发生率为1.5%，而NET + EE周期为6.6%，DSG + EE周期为2.6%；点滴出血发生率在GTD + EE周期中为4.5%，NET + EE周期为9.7%，DSG + EE周期为10.3%；突破性出血加点滴出血发生率在GTD + EE周期中为2.1%，NET + EE周期为8.1%，DSG + EE周期为4.6%。NET + EE周期中有2.0%发生闭经，但在所有给予GTD + EE的受试者中仅0.3%报告有闭经，给予DSG + EE的受试者中为0.7%。在使用任何一种研究制剂期间，周期长度和出血强度变化不大。GTD + EE方案期间撤退性出血的平均长度从（研究前）4.5天缩短至4.0天。使用每种OC时，受试者在第3周期和第6周期的平均体重与基线值相差不到0.5千克。（摘要截短至400字）
