Essential Access Health, Los Angeles, CA, USA.
University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.
Contraception. 2021 Mar;103(3):137-143. doi: 10.1016/j.contraception.2020.11.011. Epub 2020 Nov 28.
To assess the contraceptive efficacy, safety, and tolerability of a contraceptive transdermal delivery system, (TDS; TWIRLA) containing levonorgestrel (LNG) and ethinyl estradiol (EE).
This single-arm, open-label, multicenter, 1-year (13 cycle), phase 3 study enrolled sexually active women ≥18 years old at risk for pregnancy irrespective of body mass index (BMI). Women used patches in 28-day cycles (3 consecutive administrations of 7-day patches followed by 7 days off-treatment/patch-free week). We assessed contraceptive efficacy by the Pearl Index (PI) in women 18 to 35 years, excluding cycles without intercourse or when other contraceptive methods were used.
The study enrolled 2032 demographically diverse women in the US, of which 35.3% had a BMI ≥30 kg/m. In the primary efficacy analysis, the PI (95% confidence interval) was 5.8 (4.5-7.2) pregnancies per 100 woman-years. PIs trended higher as BMI increased; the PI was 4.3 (2.9-5.8) in women with BMI <30 kg/m and 8.6 (5.8-11.5) in women with BMI ≥30 kg/m. Hormone-related treatment-emergent adverse events included nausea (4.1%) and headache (3.6%); 11% of women discontinued due to adverse events. Four women (all with BMIs ≥30 kg/m) reported thromboembolic events considered related to treatment.
The low-dose LNG/EE TDS was effective in preventing pregnancy in a population of women representative of US demographics. Efficacy was reduced in women with BMI ≥30 kg/m. The TDS safety and tolerability profile was consistent with other similar dose combined hormonal contraceptives. Results of this phase 3 study supported the US Food and Drug Administration approval of TWIRLA for prevention of pregnancy in women with BMI <30 kg/m.
TDS (120 µg/day levonorgestrel and 30 µg/day ethinyl estradiol) is an effective, low-dose transdermal contraceptive patch with favorable tolerability profile approved for prevention of pregnancy in women with BMI <30 kg/m. TDS has reduced effectiveness in women with BMI ≥30 kg/m.
评估含有左炔诺孕酮（LNG）和炔雌醇（EE）的避孕经皮给药系统（TDS；TWIRLA）的避孕效果、安全性和耐受性。
这项单臂、开放性、多中心、1 年（13 个周期）、3 期研究纳入了有妊娠风险的≥18 岁的性活跃女性，无论其体重指数（BMI）如何。女性以 28 天周期使用贴片（连续 3 次使用 7 天贴片，然后停药 7 天/无贴片周）。我们通过 Pearl 指数（PI）评估了 18 至 35 岁女性的避孕效果，排除无性交的周期或使用其他避孕方法的周期。
该研究在美国入组了 2032 名具有不同人口统计学特征的女性，其中 35.3%的女性 BMI≥30kg/m。在主要疗效分析中，PI（95%置信区间）为每 100 名女性年 5.8（4.5-7.2）例妊娠。PI 随 BMI 增加而升高；BMI<30kg/m 的女性的 PI 为 4.3（2.9-5.8），BMI≥30kg/m 的女性的 PI 为 8.6（5.8-11.5）。与激素相关的治疗中出现的不良事件包括恶心（4.1%）和头痛（3.6%）；11%的女性因不良事件而停药。有 4 名女性（均 BMI≥30kg/m）报告了认为与治疗相关的血栓栓塞事件。
低剂量 LNG/EE TDS 可有效预防代表性美国人口统计学特征的女性怀孕。BMI≥30kg/m 的女性有效性降低。TDS 的安全性和耐受性与其他类似剂量的联合激素避孕药一致。这项 3 期研究的结果支持美国食品和药物管理局批准 TWIRLA 用于预防 BMI<30kg/m 的女性怀孕。
TDS（120μg/天左炔诺孕酮和 30μg/天炔雌醇）是一种有效的、低剂量经皮避孕药贴，具有良好的耐受性，批准用于预防 BMI<30kg/m 的女性怀孕。TDS 在 BMI≥30kg/m 的女性中的有效性降低。
