Louwagie Eli J, Quinn Garrett F L, Pond Kristi L, Hansen Keith A
University of South Dakota Sanford School of Medicine, 1400 W 22nd St, Sioux Falls, SD, 57105, USA.
Chair and Professor, Dept. of Obstetrics and Gynecology, University of South Dakota Sanford School of Medicine; Reproductive Endocrinologist, Sanford Fertility and Reproductive Medicine, 1500 W 22nd St Suite 102, Sioux Falls, SD, 57105, USA.
Basic Clin Androl. 2023 Nov 9;33(1):30. doi: 10.1186/s12610-023-00204-z.
Since the release of the combined oral contraceptive pill in 1960, women have shouldered the burden of contraception and family planning. Over 60 years later, this is still the case as the only practical, effective contraceptive options available to men are condoms and vasectomy. However, there are now a variety of promising hormonal and non-hormonal male contraceptive options being studied. The purpose of this narrative review is to provide clinicians and laypeople with focused, up-to-date descriptions of novel strategies and targets for male contraception. We include a cautiously optimistic discussion of benefits and potential drawbacks, highlighting several methods in preclinical and clinical stages of development.
As of June 2023, two hormonal male contraceptive methods are undergoing phase II clinical trials for safety and efficacy. A large-scale, international phase IIb trial investigating efficacy of transdermal segesterone acetate (Nestorone) plus testosterone gel has enrolled over 460 couples with completion estimated for late 2024. A second hormonal method, dimethandrolone undecanoate, is in two clinical trials focusing on safety, pharmacodynamics, suppression of spermatogenesis and hormones; the first of these two is estimated for completion in December 2024. There are also several non-hormonal methods with strong potential in preclinical stages of development.
There exist several hurdles to novel male contraception. Therapeutic development takes decades of time, meticulous work, and financial investment, but with so many strong candidates it is our hope that there will soon be several safe, effective, and reversible contraceptive options available to male patients.
自1960年复方口服避孕药问世以来,女性一直肩负着避孕和计划生育的重任。60多年后的今天,情况依然如此,因为男性可用的唯一实用、有效的避孕方法是避孕套和输精管切除术。然而,目前有多种有前景的激素和非激素男性避孕方法正在研究中。本叙述性综述的目的是为临床医生和普通大众提供关于男性避孕新策略和靶点的重点、最新描述。我们谨慎乐观地讨论了其益处和潜在缺点,重点介绍了几种处于临床前和临床开发阶段的方法。
截至2023年6月,有两种激素男性避孕方法正在进行安全性和有效性的II期临床试验。一项大型国际IIb期试验正在研究经皮醋酸西孕酮(内美通)加睾酮凝胶的疗效,已招募了460多对夫妇,预计2024年底完成。第二种激素方法,十一酸二甲双睾酮,正在两项专注于安全性、药效学、抑制精子发生和激素的临床试验中;这两项试验中的第一项预计于2024年12月完成。在临床前开发阶段也有几种具有强大潜力的非激素方法。
新型男性避孕存在几个障碍。治疗方法的开发需要数十年的时间、细致的工作和资金投入,但有这么多强有力的候选方法,我们希望很快能为男性患者提供几种安全、有效且可逆的避孕选择。