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男性避孕药的时代可能即将到来The era of male birth control may be nearing

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一种注射型避孕药正在印度研发中,而美国公司也在推进各自的版本。

An injectable contraceptive is under development in India, and U.S. companies are pursuing their own versions.

近半个世纪以来,苏乔伊·古哈一直致力于完善一种男性避孕药。如今,这位86岁印度医生的构想正获得越来越多的关注,有望改变全球避孕实践的方式。

For nearly a half-century, Sujoy Guha has worked to perfect a male contraceptive. Now the 86-year-old Indian doctor’s idea is gaining momentum, raising the prospect of changing the way birth control is practiced across the globe.

将水凝胶注入输精管——即把精子从睾丸输送出去的管道——可暂时阻止精子通过。古哈的这种注射型避孕药名为RISUG,经过数十年的研究、监管审查和官僚障碍之后,目前仍在印度研发中。但如今,美国公司正在推进各自的版本,竞相将“输精管封闭型”避孕药推向市场。

Injecting hydrogel into the vas deferens — the tubes that carry sperm from the testicles — temporarily blocks sperm from passing through. Guha’s injectable contraceptive, known as RISUG, remains under development in India after decades of research, regulatory review and bureaucratic obstacles. But now companies in the United States are pursuing their own versions, racing to bring “vas-occlusive” contraceptives to market.

NEXT Life Sciences一直在研发Plan A,该产品使用Vasalgel,其技术渊源可直接追溯到古哈的研究。这种非激素避孕药的设计有效期约为10年,并可通过第二次注射碳酸氢钠溶液来逆转,该溶液会溶解凝胶。

NEXT Life Sciences has been developing Plan A, which uses Vasalgel, tracing its lineage directly to Guha’s work. The nonhormonal contraceptive is designed to last about 10 years and can be reversed with a second injection of sodium bicarbonate solution, which dissolves the gel.

福克斯将人们对男性避孕的兴趣形容为“爆炸式增长”,该公司兴趣名单上已有5.5万名男性。他说,一段关于Plan A的视频一夜之间获得了450万次观看。

Fox describes the interest in male contraception as “explosive,” with 55,000 men on the company’s interest list. One Plan A video received 4.5 million views overnight, he said.

Contraline正在研发ADAM,这是一种非激素水凝胶,同样可阻止精子通过输精管,最初设计为可在两年内自行降解。

Contraline is developing ADAM, a nonhormonal hydrogel that also blocks sperm passage through the vas deferens, initially designed to degrade on its own over two years.

阮说:“从结构层面来看,主要问题之一实际上并不一定是男性是否愿意使用,而是当他们愿意使用时,谁能提供,他们是否负担得起?他们能否获得?”

“From a structural standpoint, one of the main issues actually is not necessarily whether or not men want to do it, but it’s when they do want to do it, who can provide it, and can they afford it? Can they access it?”Nguyen said.

“随着首批男性可逆避孕方式的出现,将会有更多的男性参与到相关讨论中来,无论这与他们是否直接相关,还是仅停留在抽象层面,亦或是以某种方式将‘避孕责任掌握在男性手中’这一理念植入社会意识,”他说道,“这是一种范式转变。”目前,男性仅有两种广泛使用的避孕方式:避孕套和输精管结扎术。女性则有十多种选择,但其中许多伴有副作用。

“With the advent of the first male reversible contraceptives, you’re going to have more men entering into conversations about it, whether directly relevant to them, or in abstract, or in ways that just put the idea of pregnancy prevention being in a man’s hands into social consciousness,” he said. “And that is paradigm-changing.”Men currently have only two widely available contraceptive methods: condoms and vasectomies. Women have more than a dozen options, many with side effects.

凯撒家庭基金会(KFF)2024年的一项调查发现,82%的育龄女性在过去12个月内使用过避孕措施。在未使用首选避孕方式的受访者中,23%的人表示她们更希望伴侣进行输精管结扎。

A 2024 KFF survey found that 82 percent of reproductive-age women had used contraception in the prior 12 months. Among contraceptive users not using their preferred method, 23 percent said they prefer that their partner get a vasectomy.

“我认为男性扪心自问自己能做什么、身体内部能承担什么、以及他们应负什么责任,这一点至关重要,”辛哈在接受采访时说,“让我们转换视角,看看这在推动性别平等进程中能真正发挥什么作用。”此外,便利性和掌控感也是其吸引力所在。

“I think it’s really important that men ask themselves what they can do, what’s inside their body, what are they responsible for,” Sinha said in an interview. “Let’s turn the lens and see what that can do truly in moving the needle towards gender equity.”There’s also the appeal of convenience and control.

福克斯在《Give it a Shot》中表示:“避孕领域的终极目标是实现长效且可逆。”目前,Plan A和ADAM在美国的监管审批进程中都进展顺利。

“The holy grail of contraception is something that’s long-lasting and reversible,” Fox says in “Give it a Shot.”Both Plan A and ADAM are well on their way down the regulatory path in the U.S.

据福克斯介绍,NEXT Life Sciences公司最近完成了二期临床试验,他形容结果“显示出了极高的安全性和有效性”。在一项涉及40名男性的试验中,Plan A被成功植入输精管,并将精子数量降至零。该公司目前正在测试该手术是否可以逆转并恢复精子水平。

NEXT Life Sciences recently completed Phase 2 clinical trials, according to Fox, with results he described as “showing incredible safety and efficacy.”In a trial involving 40 men, Plan A was successfully placed in the vas deferens and reduced sperm counts to zero. The company is testing whether the procedure can be reversed and sperm levels restored.

福克斯表示,三期试验即将开始,并补充说公司目标是在2028年获得美国食品药品监督管理局(FDA)的批准。“我们现在正在打好基础,以确保在全球范围内推出,”他说。

Phase 3 trials will begin soon, Fox said, adding that the company is aiming to win approval from the Food and Drug Administration in 2028. “We are laying the groundwork now to ensure a worldwide launch,” he said.

ADAM的首项人体研究属于概念验证阶段——这是在进行更大规模的有效性研究以获得监管批准之前,评估安全性和可行性的第一步。

ADAM’s first human study was proof-of-concept — a first step to assess safety and feasibility, before a larger efficacy study to gain regulatory approval.

自那以后,Contraline公司对产品进行了重新设计,使其使用更加便捷,并延长了水凝胶的使用寿命。

Contraline has since redesigned the product to be faster to use and extend the hydrogel’s lifespan.

“下一步将是针对ADAM 2.0产品进行临床研究,包括评估其避孕效果的反转程序(即恢复生育能力的程序),”Eisenfrats说道。

“The next major step is a clinical study of ADAM 2.0, including evaluating the reversal procedure,” Eisenfrats said.

Eisenfrats还表示,该公司最近获得了9250万美元的融资资金;其中大部分资金将用于开发NES/T——这是一种专为男性设计的激素避孕凝胶产品,因为该项目的临床研究进展更为成熟。

The company recently received $92.5 million in financing, Eisenfrats said. The larger share will go toward NES/T, the company’s hormonal contraceptive arm/shoulder gel for men, as it is the more clinically advanced program, he added.

相比之下,RISUG(另一种避孕技术)的发展历程要漫长得多。

RISUG, meanwhile, has traveled a much longer path.

纪录片《Give It a Shot》不仅展示了这项技术的演变过程,还揭示了其背后的历史背景:20世纪70年代,印度曾大规模推行绝育计划,约有600万男性被迫接受了输精管结扎手术。此后,避孕的重点逐渐转向了女性。

“Give it a Shot” highlights the evolution of the technology, as well as the history behind it — the massive 1970s “sterilization drive,” in which more than 6 million men were targeted for forced vasectomies. Since then, the focus has shifted to women. Today, sterilization is the dominant contraceptive for women across the world.

纪录片在印度拉贾斯坦邦西部城市奇托尔加尔(Chittorgarh)进行了拍摄,那里的许多女性分享了她们接受绝育手术的经历。其中一位女性开玩笑说:“我认识的唯一一个同意接受输精管结扎手术的男性,竟然有14个孩子,而他的妻子却拒绝接受同样的手术。”

The documentary spends time in Chittorgarh, a major Indian city in the western state of Rajasthan, where about a dozen women spoke about their experience with sterilization. One woman drew laughs when she shared that the only man she knew who agreed to a vasectomy had 14 kids and a wife who refused the operation.

“这些夫妇之间充满了幸福感,”Sinha说道,“他们在谈论RISUG技术及其实施过程时表现出一种平等的态度。”她指出,在印度,共有500名男性自愿参与了这项技术的临床试验。

“There was a great sense of joy between these couples,” Sinha said, “and equity that I sensed from their conversation when they would talk about RISUG and how that was navigated and negotiated.”She noted that 500 men in India stepped up to participate in a clinical trial.

Sinha还指出了RISUG在印度推广过程中遇到的障碍:主要制药公司对此缺乏兴趣;无论是非营利组织、政府还是私营企业,都未将这项技术纳入他们的优先发展计划。该技术的使用方法是在输精管上制造一个微小的开口以便注射药物,随后只需用绷带包扎并稍作观察即可。

Sinha identified hurdles the contraceptive has faced in India, including lack of interest among major pharmaceutical companies and “the lack of this being on anyone’s agenda, whether nonprofits, governments, or capitalists.”To administer it, a pinhole-size opening is made to expose the vas for injection, followed by a bandage and brief observation.

辛哈回忆起有个人自豪地对她说:“女士,30分钟后我就可以骑着我的摩托车回家了。”这位电影制作人表示,在印度,这被视为一种荣誉的象征。“这意味着你敢于骑上摩托车,勇敢地驶上那些崎岖不平的道路。”

Sinha recalls one man proudly telling her, “Madam, in 30 minutes, I was good to go back home on my scooter.”The filmmaker says that’s a badge of honor in India. “It means you put your balls on your motorbike and you’re good to go on the bumpy roads.”