Department of Gynecology and Obstetrics, Ribeirao Preto Medical School, University of São Paulo, Avenida Bandeirantes, 3900 - Campus Universitário - Monte Alegre, CEP: 14049-900, Ribeirão Preto, SP, Brazil.; Population Council, 1230 York Avenue, New York City, NY, 10065, USA..
The University of New South Wales, School of Women's and Children's Health, Royal Hospital for Women, Barker Street, Randwick, NSW 2031, Australia.
Contraception. 2019 Dec;100(6):438-444. doi: 10.1016/j.contraception.2019.07.145. Epub 2019 Aug 6.
To describe bleeding patterns among users of the segesterone acetate (SA) and ethinyl estradiol (EE) contraceptive vaginal system (CVS), and identify factors associated with unscheduled bleeding/spotting (B/S).
We pooled results from two multicenter, single-arm, open-label, pivotal, phase 3 studies of the SA/EE CVS conducted in 17 US and 7 international sites. Participants (age 18-40 years; BMI ≤29 kg/m) followed a 21/7-day in/out schedule of CVS use for up to 13 cycles and recorded vaginal bleeding daily in paper diaries. Scheduled and unscheduled B/S were summarized by cycle. We used multiple logistic regression to identify factors associated with unscheduled bleeding/spotting, based on the first 4 cycles only.
Analysis included data from 2070 participants (16,408 cycles). Ninety-eight percent documented scheduled B/S [mean (SD): 4.9 (1.1) days/cycle)]. Absence of scheduled B/S was 5-8% of women/cycle. Unscheduled B/S ranged from 13.2% to 21.7% of women per cycle. Few women (1.8%) discontinued prematurely due to unacceptable bleeding. Black women were more likely to report unscheduled B/S than White women [Adjusted odds ratio (AOR) = 1.49, 95% confidence interval (CI) = 1.14-1.94]. Women with fewer years of schooling [<high school (AOR=0.62, 95% CI=0.43-0.90); high school graduate (AOR: 0.76, 95% CI=0.60-0.97)] were less likely to report any episode of unscheduled B/S compared to college graduates.
Participants using the SA/EE CVS up to 13 cycles reported good cycle control. Discontinuation due to unacceptable bleeding was very low. Further research into demographic/other differences with reported unscheduled bleeding is warranted.
Since good cycle control is a key factor influencing contraceptive selection, adherence and continuation of combined hormonal contraceptives, the favorable bleeding profiles experienced by women during the SA/EE CVS clinical trials provide reassuring information for prospective users.
描述醋酸甲羟孕酮（SA）和炔雌醇（EE）避孕阴道环（CVS）使用者的出血模式，并确定与非计划性出血/点滴出血（B/S）相关的因素。
我们汇总了在美国 17 个和国际 7 个地点进行的 2 项多中心、单臂、开放标签、关键性、3 期 SA/EE CVS 研究的结果。参与者（年龄 18-40 岁；BMI≤29kg/m²）按照 CVS 使用的 21/7 天出入方案，最多使用 13 个周期，并在纸质日记中每天记录阴道出血情况。根据前 4 个周期，总结了每个周期的计划内和非计划性 B/S。我们使用多因素逻辑回归来确定与非计划性出血/点滴出血相关的因素。
分析包括 2070 名参与者（16408 个周期）的数据。98%的人记录了计划内的 B/S[平均（SD）：4.9（1.1）天/周期)]。每个周期有 5-8%的女性没有出现计划内的 B/S。每个周期有 13.2%-21.7%的女性出现非计划性 B/S。由于出血不可接受，很少有女性（1.8%）提前停药。黑人女性比白人女性更有可能报告非计划性 B/S[调整后的优势比（AOR）=1.49，95%置信区间（CI）=1.14-1.94]。受教育程度较低的女性（未完成高中学业（AOR=0.62，95%CI=0.43-0.90）；高中毕业（AOR：0.76，95%CI=0.60-0.97]）报告任何非计划性 B/S 的可能性低于大学毕业的女性。
使用 SA/EE CVS 13 个周期的参与者报告了良好的周期控制。由于出血不可接受而停药的情况非常低。需要进一步研究报告的非计划性出血与人口统计学/其他差异。
由于良好的周期控制是影响复方激素避孕药选择、依从性和续用的关键因素，因此在 SA/EE CVS 临床试验中，女性经历的良好出血模式为预期使用者提供了令人安心的信息。
