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A technology evaluation of Annovera: a segesterone acetate and ethinyl estradiol vaginal ring used to prevent pregnancy for up to one year.
Expert Opinion on Drug Delivery ( IF 6.6 ) Pub Date : 2020-05-15 , DOI: 10.1080/17425247.2020.1764529
Elizabeth A Micks 1 , Jeffrey T Jensen 2
Affiliation  

Introduction: 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).Areas covered: 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.Expert opinion: 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.

中文翻译:

Annovera的技术评估:醋酸塞格列酮和炔雌醇阴道环可预防长达一年的妊娠。

简介:醋酸塞格列酮和乙炔雌二醇避孕阴道环(SA / EE CVR)于2018年8月获得FDA批准,现已在美国上市。将CVR阴道放置21天,然后间隔7天,无环间隔,停药时通常会发生出血。一枚戒指最多可以使用一年(13个周期)。涵盖范围:这篇综述总结了这种新颖的避孕方法,包括分娩系统和荷尔蒙成分。我们描述了潜在的市场,使用方法,设备的药代动力学特性以及包括功效,出血情况,可接受性和安全性在内的临床试验结果。专家意见:SA / EE CVR代表着第一个长期的用户-控制性激素避孕装置。全年的出血模式非常有利且一致,并且停药率极低。功效和安全性类似于激素结合避孕药的其他方法。计划外的环拆卸会增加发生故障的风险。需要进一步的研究来评估连续使用环超过21天以及环的潜在非避孕益处,例如减少月经出血。
更新日期:2020-05-15
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