Department of Obstetrics and Gynecology, University of Washington , Seattle, WA, USA.
Department of Obstetrics and Gynecology, Oregon Health & Science University , Portland, OR, USA.
Expert Opin Drug Deliv. 2020 Jun;17(6):743-752. doi: 10.1080/17425247.2020.1764529. Epub 2020 May 15.
The segesterone acetate and ethinyl estradiol contraceptive vaginal ring (SA/EE CVR) was FDA-approved in August 2018 and is now available in the U.S. The CVR is placed vaginally for 21 days followed by a 7-day ring-free interval, when withdrawal bleeding typically occurs. One ring can be used for up to a year (13 cycles).
This review summarizes this novel method of contraception, including the delivery system and the hormonal components. We describe the potential market, how it is used, the pharmacokinetic properties of the device, and results of clinical trials including efficacy, bleeding profile, acceptability, and safety.
The SA/EE CVR represents the first long-lasting user-controlled hormonal contraceptive device. The bleeding pattern is highly favorable and consistent over the entire year and is associated with very low discontinuation. Efficacy and safety are similar to other methods of combined hormonal contraceptives. Unscheduled ring removals increase the risk of failure. Further studies are needed to evaluate continuous use of the ring for greater than 21 days, and potential non-contraceptive benefits of the ring such as reduced menstrual bleeding.
醋酸炔诺酮和炔雌醇避孕阴道环（SA/EE CVR）于 2018 年 8 月获得 FDA 批准，现已在美国上市。阴道环放置 21 天后，会有 7 天的无环间隔期，通常在此期间会出现撤退性出血。一个环最多可使用一年（13 个周期）。
本综述总结了这种新型避孕方法，包括输送系统和激素成分。我们描述了其潜在的市场、使用方法、装置的药代动力学特性以及临床试验结果，包括疗效、出血模式、可接受性和安全性。
SA/EE CVR 代表了首个长效、使用者控制的激素避孕装置。整个一年的出血模式非常理想且一致，与极低的停药率相关。疗效和安全性与其他复方激素避孕药相似。非计划取出阴道环会增加失败的风险。需要进一步研究来评估连续使用环超过 21 天的情况，以及环的潜在非避孕益处，如减少月经出血。
