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低剂量左炔诺孕酮和炔雌醇贴片与丸：一项随机对照试验。

Low-dose levonorgestrel and ethinyl estradiol patch and pill: a randomized controlled trial.

机构信息

Department of Obstetrics and Gynecology, University of Florida College of Medicine, Jacksonville, Florida; the Columbus Center for Women's Health Research, Columbus, Ohio; Mailman School of Public Health, Columbia University, New York, New York; the Jones Institute for Reproductive Medicine, Eastern Virginia Medical School, Norfolk, Virginia; the Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, California; ARSTAT, Flemington, New Jersey; and Agile Therapeutics, Inc, Princeton, New Jersey.

出版信息

Obstet Gynecol. 2014 Feb;123(2 Pt 1):295-303. doi: 10.1097/AOG.0000000000000095.

DOI:10.1097/AOG.0000000000000095

PMID:24402597

Abstract

OBJECTIVE

To compare a new low-dose levonorgestrel and ethinyl estradiol contraceptive patch (Patch) with a combination oral contraceptive (Pill; 100 micrograms levonorgestrel, 20 micrograms ethinyl estradiol) regarding efficacy, safety, compliance, and unscheduled uterine bleeding.

METHODS

Women (17-40 years; body mass index 16-60) were randomized in a 3:1 ratio to one of two groups: Patch only (13 cycles) or Pill (six cycles) followed by Patch (seven cycles). Investigators evaluated adverse events during cycles 2, 4, 6, 9, and 13. Participants recorded drug administration and uterine bleeding on daily diary cards. Compliance was assessed by measuring levonorgestrel and ethinyl estradiol plasma levels. Pearl Index (pregnancies per 100 woman-years) was calculated to evaluate efficacy.

RESULTS

Participants (N=1,504) were randomized to Patch (n=1,129) or Pill (n=375). Approximately 30% were obese, more than 40% were racial or ethnic minorities, and more than 55% were new users of hormonal contraceptives. Laboratory-verified noncompliance (undetectable plasma drug levels) was 11% of Patch and 12.6% of Pill users at cycle 6. Pearl Indices (95% confidence intervals) for the intention-to-treat population (cycles 1-6) were 4.45 (2.34-6.57) for Patch and 4.02 (0.50-7.53) for Pill; excluding laboratory-verified noncompliant participants, Pearl Indices were 2.82 (0.98-4.67) for Patch and 3.80 (0.08-7.52) for Pill (differences not statistically significant). Incidence of unscheduled bleeding and incidence and severity of adverse events were similar for both contraceptives (no statistically significant difference).

CONCLUSIONS

Efficacy and safety of the new contraceptive Patch are comparable to those of a Pill. Laboratory-verified noncompliance and bleeding profile are similar between the two treatments. The Patch was well tolerated.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, www.clinicaltrials.gov, NCT01181479.

LEVEL OF EVIDENCE

摘要

目的

比较一种新的低剂量左炔诺孕酮和炔雌醇避孕贴（贴片）与复方口服避孕药（药丸；左炔诺孕酮 100 微克，炔雌醇 20 微克）在疗效、安全性、顺应性和非计划性子宫出血方面的差异。

方法

17-40 岁的女性（体重指数 16-60）按 3：1 的比例随机分为两组：仅使用贴片（13 个周期）或药丸（6 个周期），然后使用贴片（7 个周期）。在第 2、4、6、9 和 13 个周期中，研究者评估了不良事件。参与者使用每日日记卡记录药物使用情况和子宫出血情况。通过测量左炔诺孕酮和炔雌醇的血浆水平来评估依从性。妊娠率（每 100 名妇女-年的妊娠数）用于评估疗效。

结果

参与者（N=1504）被随机分配到贴片组（n=1129）或药丸组（n=375）。约 30%为肥胖者，超过 40%为少数民族，超过 55%为激素避孕药的新使用者。在第 6 个周期，实验室证实的不依从性（无法检测到血浆药物水平）在贴片组为 11%，在药丸组为 12.6%。意向治疗人群（第 1-6 个周期）的妊娠率（95%置信区间）为 4.45（2.34-6.57）的贴片和 4.02（0.50-7.53）的药丸；排除实验室证实的不依从参与者，妊娠率分别为 2.82（0.98-4.67）的贴片和 3.80（0.08-7.52）的药丸（差异无统计学意义）。两种避孕药的非计划性出血发生率、不良反应发生率和严重程度相似（无统计学显著差异）。