A Male Birth Control Pill Moves to the Next Clinical Trial Stage

Rachel Feltman: For American scientist‘s Science quickly, I am Rachel Feltman.

Regarding birth control, men have exactly two reliable options: condoms or vasectomy. That’s it. For decades, researchers have been working to extend these choices, but progress has been slow.

Now, a new pill for men has just passed his first security test in humans. What is particularly exciting in this daily pill, which works by blocking a key step in the production of sperm is that it is without hormones.

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Here, to tell us more about the latest progress on male contraception is Hannah SEO, an independent scientific journalist based in Brooklyn.

Hannah, thank you very much for coming to discuss today.

Hannah SEO: Thank you for doing me. It’s exciting.

Feltman: So you recently wrote a story to American scientist About some progress in male birth control. Could you start by simply telling us what is this particular method and, and how it works?

SEO: Yeah, I was really fascinated to read this trial because it is the first control of non -hormonal male births pill. Thus, a large part of the contraception methods that we think generally involve hormones of a kind or imply a kind of surgery, on the right, as a vasectomy. But that doesn’t make any of these things. It is a pill which is supposed to be taken daily, and this prevents the production of sperm from occurring by non -hormonal methods, so I thought it was a truly innovative medicine that is being developed.

Feltman: Could you tell us more about the mechanism by which it prevents the production of sperm?

SEO: Yes, absolutely. So, one thing that is interesting to note is that in people of all sexes, if you have a severe deficiency of vitamin A, it can really have an impact on your fertility, and therefore the manufacturers of this medication were really focused on this detail. And what they discovered is that the testicles cells will take vitamin A, metabolize vitamin A in this metabolite called retinoic acid; Retinoic acid will be linked to a receptor, and in this connection, it will cause changes in the expression of genes which lead to the production of sperm – there is, like, an effect cascade, and the consequence is that you get sperm.

And so what this medication does is that it prevents the connection from happening …

Feltman: MM.

SEO: It prevents retinoic acid from binding to its receiver. And consequently, it breaks the chain and, you know, all the different effects cannot really cascade as they would – normally, and you prevent the production of sperm in this way. And then once you have stopped taking the drug, after a while, you finally find this function.

Feltman: Just, you know, remind us: where are we with the control of male births in general at the moment? You know, what is available, what’s going on?

SEO: Yes, what people can currently include two things: you can get a vasectomy, or you can use condoms. And so, with regard to male contraception, these are really the only two options, and none of these is particularly ideal, especially if you are someone who wants a reversible option to control your fertility.

Currently, there are several development options, including this pill, which is a non -hormonal contraceptive pill taken daily. There is also a gel – I think many people will have heard of this gel. It is called Nest / T, which means a progestogy called Nestorone, as well as testosterone. People who make replacement hormone therapy will use a similar gel on their shoulders. It is a very, very similar mechanism. And it works a bit in the same way as the non -hormonal pill in that it stops sperm production in a reversible way. It is therefore probably the male contraceptive that is most distant from development. This is currently at the dawn of the starting phase 3 clinical trials.

There is also a reversible vasectomy. Some vasectomies, currently, are surgically reversible but not all, and this quote, Unbote, “reversible vasectomy” is really an implant. And what is is that it is a small tiny hydrogel that can be inserted into the vas vas, and it simply prevents the sperm from being able to escape in the ejaculate. And so it is also far enough in development.

And it is really the two that are closest to free themselves on the market. In addition to these two, we then have this non-hormonal contraceptive pill which stops the production of sperm and, like, a few other smaller options which are also somehow at the start of early development.

Feltman: Yeah, so speaking of CE: where is this pill in development? I know there [was] Some recent news on progress, but where does that leave us?

SEO: So this pill has just finished a 1A clinical trial, and that means that it has not yet been tested for efficiency; It was only tested for security. So in this trial – and it was a very small trial; It only involved, you know, like a dozen healthy men – in this little try, what was essentially tested was the way people reacted to the pill …

Feltman: MM.

SEO: And if the levels of this medication have remained in the blood or not during, as, an adequate period of time.

And so this new development is exciting because it means that this pill is sure to take at the levels that we expect that this pill can be taken if it goes on the market, but we still do not really have data on the way in which [effectively] It can reduce the sperm that people’s bodies produce.

Feltman: Yeah, and was there side effects or, you know, everything that came during the trial?

SEO: So it looks really good so far. I would say that this trial was quite small, only 16 men, and he also did not involve taking this medication for a long, long [period] time. And so even if there has been no side effects noted in the trial they finished, we still have a long way to go to find out if someone will have side effects once they are starting to use it daily for months or years.

Feltman: So what are the next steps in this medication?

SEO: Yes, so the next step in this drug is that they now undergo a 1B clinical trial and a clinical trial 2A, and what it means is that they will be more important trials involving more people who take this medication for, you know, more doses at the same time and assess not only safety but also efficiency. They will therefore begin to measure the number of sperm and see if the production of sperm reduces or not over time and, in the affirmative, by how much and how different doses of the drug affect this efficiency.

Feltman: Very cool. And what is the chronology to obtain from where this medication is now to really reach the market?

SEO: It’s a great question and [laughs] Whoever, I think, is not entirely predictable, for a number of reasons. You know, of course, to ensure that this drug markets it involves, you know, it [Food and Drug Administration] And, as, government regulators, and sometimes it may be, you know, not so predictable.

I spoke to someone who was involved in the management of this trial, and she said that she hoped that this drug would arrive on the market in the coming years, as less than five years. And I think it is possible, provided that the next tests take place smoothly, that no major side effects are reported and that the government assesses security and etc. In a timely manner – I think it may be an unpredictable part.

But I think there is a request for contraceptive options, in particular more male contraceptive options, and I think that the public feeling of wanting various options to control that the agency will contribute, you know, these methods available soon and the pressure, as, push them through and available on the market.

Feltman: Thank you very much for coming to tell us about this story, Hannah.

SEO: Great. It was a pleasure to be here.

Feltman: That’s it for today’s episode. We will be back on Friday for an overview of the adventurous area known as experimental archeology.

Science quickly is produced by me, Rachel Feltman, with Fonda Mwangi, Kelso Harper and Jeff Delviscio. This episode was published by Alex Sugiura. Shayna has and Aaron Shattuck checks our show. Our theme music was composed by Dominic Smith. Subscribe to American scientist For new scientists up to date and in -depth.

For Scientific American, Here is Rachel Feltman. See you next time!