University of Washington, Division of Metabolism, Endocrinology and Nutrition, Seattle, Washington, USA.
Curr Opin Endocrinol Diabetes Obes. 2024 Dec 1;31(6):236-242. doi: 10.1097/MED.0000000000000880. Epub 2024 Aug 19.
Rates of unintended pregnancy have remained relatively stagnant for many years, despite a broad array of female contraceptive options. Recent restrictions on access to abortion in some countries have increased the urgency for expanding contraceptive options. Increasing data suggest men are keen to utilize novel reversible male contraceptives.
Despite decades of clinical research in male contraception, no reversible hormonal product currently exists. Nestorone/testosterone, among other novel androgens, shows promise to finally move to pivotal Phase 3 studies and introduction to the marketplace.
Hormonal male contraception utilizes androgens or androgen-progestin combinations to exploit negative feedback that regulates the hypothalamic-pituitary-testicular axis. By suppressing release of gonadotropins, these agents markedly decrease endogenous testosterone production, lower intratesticular testosterone and suppress spermatogenesis. The addition of a progestin enhances the degree and speed of sperm suppression. The androgen component preserves a state of symptomatic eugonadism in the male. There is growing demand and acceptance of male contraceptive options in various forms. As these formulations progress through stages of drug development, regulatory oversight and communication with developers around safety and efficacy standards and garnering industry support for advancing the production of male contraceptives will be imperative.
尽管有多种女性避孕选择，但多年来，意外怀孕的发生率仍相对停滞不前。最近一些国家对堕胎的限制增加了扩大避孕选择的紧迫性。越来越多的数据表明，男性热衷于使用新型可逆男性避孕药。
尽管男性避孕药已有数十年的临床研究，但目前尚无可逆的激素类产品。去氧孕烯/睾酮等新型雄激素类药物有望最终进入关键的 3 期研究并推向市场。
激素男性避孕药利用雄激素或雄激素-孕激素组合来利用调节下丘脑-垂体-睾丸轴的负反馈。这些药物通过抑制促性腺激素的释放，显著降低内源性睾酮的产生，降低睾丸内睾酮水平并抑制精子发生。孕激素的添加增强了精子抑制的程度和速度。雄激素成分使男性保持有症状的正常性腺状态。各种形式的男性避孕药的需求和接受度都在不断增加。随着这些制剂在药物开发的各个阶段取得进展，监管机构必须对安全性和有效性标准进行监督和与开发者进行沟通，并争取行业支持以推进男性避孕药的生产。
