Male Hormonal Contraception: Why Don’t Men Have a Birth Control Pill? (Episode 573)

Full Transcript: Episode 573

Lisa Hendrickson-Jack: This is the Fertility Friday Podcast, episode number 573.

In today’s episode, we are touching on a really interesting topic. I’m going through a paper that is looking at male contraception and really examining the question of why don’t we have a hormonal contraceptive for men yet? You know, women have had these hormonal contraceptive options for over 60 years. What’s the holdup? Is there a reason that we are not seeing more medical advances in the field of male contraception? I think there’s several reasons for this, which we’re going to talk a little bit more about today. And I think it’s going to be really interesting because of course I feel like there’s a double standard here. And I do feel like they’re a lot more concerned about the side effects when it comes to men versus the level of concern or lack thereof that they’ve had for women using similar formulations. But that and more coming up. So let’s go ahead and get into today’s episode.

So as we know, the current options for contraceptives for men are limited. There are condoms, withdrawal, and sterilization. That’s basically it. So in terms of the question of why we haven’t seen advances in this area of hormonal contraceptives for men, I think that there’s a few reasons. One, I think that because the market for female contraceptives is so big — it is a multi-billion dollar per year industry, well over 20 or 30 billion dollars — they estimate that over 100 million women worldwide use contraceptives. And medical professionals are instructed to put women on birth control as soon as possible, not only for contraceptive reasons, but there’s a long list of other reasons. I mean, anything really — any issue you have with your period, any issue you have with your cycle, any issue you have even with acne or with moods or whatever, pill, pill, pill, pill, pill. And then when you are ready to have a baby, they say, “Okay, come off and have a baby.” But as soon as you’re done having a baby, they want you to go back on. And ultimately they want you to be on the pill until you go through menopause. And then when you go through menopause, they want you on HRT. So at the end of the day, this is a multi-billion dollar industry, and I do believe that part of the reason we haven’t seen that development in male contraception is because they’re afraid that it would dip into their kind of money pot, if you will.

The other issue is — I do get this sense after reading through many papers of male contraceptive trials, including this paper — there are certain side effects that do crop up. But what I have observed is that when these side effects come up in men, there does seem to be more interest. There does seem to be more concern. And so, for example, one of the challenges with creating a male contraceptive is that in order to suppress sperm production, they need to find a way to suppress testosterone, because testosterone is highly correlated with sperm production. In order to get a man to stop making sperm, they need to suppress his testosterone. But if you suppress testosterone to a certain level, then you run the risk of interfering with his sexual function — interfering with his ability to have and maintain an erection and achieve sexual satisfaction. So then you have this magic window of how much you can suppress the testosterone while still maintaining his sexual function. And when you read the studies and you see that this is one of the things that they’re concerned about — when there are issues with sexual function or mood changes, or there was one study that reported increased aggressive tendencies and different mood changes — there does seem to be more of a kind of immediate concern around these things. Whereas with women, I don’t feel that there’s that same level of concern.

If you look into pill research, hormonal contraceptive research, there is a significant issue with how the pill affects sexual function. There are studies that show that the pill significantly decreases testosterone levels in women, and many women experience a thinning of the vulvar tissues — those are the tissues around the vaginal opening, including the clitoris. Numerous studies have shown that this significant drop of testosterone has a negative impact on female sexual function. And some studies even show that some women report a more difficult time achieving orgasm, having less arousal, having less sexual interest. But that’s not really considered to be a problem. It’s not like women complaining about sexual changes has ever stopped the pill formulations from coming out in any way. Yet when these types of issues come up in the research around male contraception, it seems like they’re a lot more concerned about it.

So as I mentioned, one of the challenges is finding the right dose in terms of the hormones they’re trying to administer. Another issue is how they administer it — transdermal, oral, injection, slow release. All of these are important factors because for men doing oral dosing, their bodies are metabolizing it very quickly. So therefore the effect may not be consistent, whereas perhaps in women they found a way to organize that so it’s not as much of a problem.

One thing I should mention: by going through this information, by no means am I saying that I actually think it’s a good idea for men to have hormonal contraception. After spending so much time talking about the pill and all the potential negative effects it has on women, going through research studies, talking with thousands of women over the years, interviewing many women on this podcast who share their experiences — it’s clear that adding in hormones changes a woman’s body in ways that we wouldn’t necessarily anticipate. So I’m not necessarily saying I think it’s a fantastic idea to introduce this can of worms with men as well. I think it is worthwhile to have this conversation, to look at the research, to look at the implications, and then to really ask: is this a good idea? But at the end of the day, women have been subjected to this hormonal contraceptive situation for so long — almost 70 years, because the first pill came out in 1960. So why is there this double standard? Why is it okay for women but not men?

So when they’re looking to formulate a contraceptive option for men, what they’re trying to do is administer these hormones in such a way that it is going to severely restrict sperm production or cause there to be no sperm at all. They are typically looking to get the sperm concentration below 3 million sperm per milliliter or below 1 million sperm per milliliter. To put it into perspective, according to the World Health Organization, a sperm concentration of 15 million per milliliter or below would be a problem. So having a hormonal situation that would reduce a man’s sperm count to barely a million sperm per milliliter or less would then make it theoretically an effective contraceptive method.

There was one study conducted by the World Health Organization where, depending on the ethnicity of the men, there was a difference in terms of how effective the drug was. The study said that nearly 60% of non-Chinese and over 90% of Chinese men attained azoospermia — meaning no sperm — based on the administration of testosterone they were given. I thought that was interesting. It speaks to the fact that male bodies aren’t all the same. Even if you give the same hormone to a group of men, some respond slightly differently to others. The remainder were severely oligospermic — under 3 million sperm per milliliter. And the pregnancy rate was really low. So in many ways this trial was quite effective. But when you read stuff like this, the question is: why didn’t it go forward? Because although it worked to suppress the sperm, there were other issues — issues with libido, depression, mood changes. They hadn’t quite worked it all out. And even though a lot of these issues are very similar to the issues women still struggle with with contraceptives, it was enough that they haven’t really moved forward and actually released anything.

There were a few other trials that detailed studies where men were given a monthly injection of testosterone. And one of the interesting things is that it’s not an instant thing. If you think about how sperm is made, research tells us it takes an average of about 74 days — so roughly three months — for sperm to be produced. So when these men are given testosterone, they are not instantly infertile. It typically takes about three months before they’re showing sperm levels below 3 million or 1 million sperm per milliliter, depending on their specific criteria. With female contraception, it’s typically taking effect quite quickly, but with male contraception, it takes a little bit longer. And the efficacy rates vary — some studies show a really high efficacy rate where only 1% or less of participants may have conceived, but some were showing a failure rate of 6% or 5%. So they’re still working out the kinks.

Some of the new formulations they’re trying combine testosterone with progestin — so synthetic progestin, synthetic testosterone. The thought is that if they use the progestin to suppress sperm production by interfering with the hypothalamic-pituitary-gonadal axis, then they can add a little bit of testosterone to make up for how much has been reduced and potentially alleviate some of those sexual side effects. In order to stop sperm production, they have to lower the testosterone, but when you lower the testosterone, it can have detrimental effects on male sexuality. So they have to find a way to suppress the sperm but give a little bit back — add in some synthetic testosterone so that he can still have sexual function without sperm production.

Now, one study that I’ve spoken about before — I wrote about it in The Fifth Vital Sign. This study was of 320 healthy fertile men. They administered testosterone by injection. This was the study that was stopped midway. The testosterone was successful in suppressing sperm production, and the pregnancy rate in the study was only 1.57% — very high efficacy, equivalent to the kind of contraceptive methods we are comfortable with. But the study was terminated early because a safety committee jumped in and said the side effects these men are experiencing are too high. Some of these men were experiencing mood changes, depression, pain at the injection site, and increased libido. During the study, there was one death by suicide that occurred at some point after they had been administering the testosterone. They said in the study they don’t think it’s related, but they still called off the study. That’s an interesting study if you’ve never heard of it before. It’s super agitating because women have been dealing with very similar side effects for 65 years and no one ever called that study off.

In addition to the side effects already mentioned, other studies have found some concerning findings in men specifically — testosterone therapy may be associated with increases in cardiovascular disease risk, including myocardial infarction and stroke. And again, some of these risk factors are similar to the increase in blood clots and stroke in women. But in the realm of male contraception, it is enough to get them to stop until they’re able to mitigate that risk. With female contraception, even though there are similar risk factors, they just put a warning label on it. But for the male contraceptive industry, this increased cardiovascular risk is enough to make researchers and the industry pause until they can improve the formulation. They’re actually looking for ways to suppress sperm production that are not going to interfere with the hormone situation, cause sexual dysfunction issues, or raise cardiovascular concerns. And this is one of the big reasons why there hasn’t been the same level of advancement with male contraception.

One other factor I want to mention — they talk about it in the paper, but I would say they’re not really talking about it with the same level of concern they should. And I have a significant concern with male hormonal contraception: how long it takes for men to recover normal sperm production. That’s a huge problem. There are a number of studies that have shown that when men are given exogenous testosterone — even if it’s not for contraception, even if a man has low testosterone and his doctor gives him testosterone replacement, or if a man is taking steroids — it is known to significantly lower sperm production. And when you stop giving him the testosterone, it can take anywhere from one to two years or more for his sperm production to fully restore and normalize. One to two years.

In this paper, they said recovery to greater than 20 million sperm per milliliter occurred in nearly all participants by 12 months. But is 20 million per milliliter optimal? No, it’s not. The research shows that optimal sperm production is somewhere around 50 million sperm per milliliter. And other studies show it can take up to two years. Even when they look at it, the probability of recovery to 20 million within 12 months was 90% and 100% within 24 months in one of the studies mentioned. But I would say that’s a pretty significant issue that they’re kind of skirting.

So in terms of the big reasons why we don’t have a male hormonal contraceptive option — the industry doesn’t want to mess with their cash cows, they haven’t found a formulation free of these side effects, they’ve had challenges finding something that can suppress sperm without having this effect on sexual function and hormonal interaction. The researchers seem super concerned about those side effects. I don’t know that they’re as concerned about sperm recovery, but I do think that would become a big factor if not all men are back to normal within a year or two — especially for couples trying to get pregnant. And I’ve seen this on the flip side with fertility clients whose partners were taking steroids for gym goals, or even being given testosterone because their levels were low. A lot of men who are taking testosterone for one reason or another have no idea that it causes them to have virtually no sperm count, and certainly they’re not aware of how long it would take to recover normal sperm production after that.

So according to this study, there’s promising new research, some promising formulations — it’s kind of like any minute now we’re going to have it. And they’re doing a little bit of damage control: most of the side effects are pretty minimal and the efficacy is really high. But when you go through everything in its entirety, you can see there are still some major concerns. And even though all these years they’ve been doing trials since the ’70s showing that hormonal contraceptive options for men can reliably lower testosterone levels and could theoretically be made into an effective formulation — they just keep kicking the can down the road because they’re super concerned about the side effects. And they should be concerned about the side effects. But I feel like they should also be concerned about the side effects for women, and they’re not.

So what do you think? I’d be really curious to know what you think about this state of affairs. Do you think they should go ahead and push out a contraceptive option for men? Frankly, I think it would cause a lot of chaos. These men would certainly be at a greater risk of various different side effects because it is messing with their hormones. It could definitely have a negative effect on sexuality and sexual function. It could definitely change moods. There’s also the cardiovascular risk — the risk of heart attack, stroke. I can’t get behind all of that, because I’m not really behind it as far as the women are concerned either. But because I work with a lot of fertility clients and practitioners who are looking to support fertility clients, introducing something like this could have a really significant effect on fertility given the duration of time it can take for men to recover their normal sperm production. So I do think there are some significant red flags here.

I feel like they’ve just taken a lot more care and a lot more time. They’ve been at this for decades. I couldn’t believe it when I saw they’ve been doing studies since the ’70s. And because of these issues, they have stopped — whereas the studies on women’s hormonal contraceptive options show very similar, if not the exact same identical side effects, yet these drugs are out and we’re just sitting ducks.

So if you’re anything like me, I suppose we’ll just kind of wait patiently to see what happens, to see if they really do come out with a male contraceptive and to see how they’re going to manage this side effect conversation. I do think that if they do decide to come out with something, the side effect conversation is going to be very, very different. I just don’t think that they’re going to get away with giving men a significantly increased cardiovascular risk and having a really negative impact on their sexual health the way they have with female contraception. I feel like it’s just going to be a totally different situation. And I think that’s the reason they haven’t done it — because they know they can’t get away with it to the same degree they have been for the last 65 years with women.

I hope you have a wonderful weekend, whenever you’re tuning in to the show. And of course, as always, until next time — be well and happy charting.