Feb 1, 2022

The clinical trial is looking for participants in Utah and elsewhere. Find out if you qualify for the study by clicking here.


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Scot: Who has a dog?

Troy: Sorry.

Scot: Was that yours? Was that Charlotte?

Troy: That was Charlotte. If I didn't let her in the room, she would be scratching at the door. So that's where we are.

Scot: Today on "Who Cares About Men's Health," we're going to learn more about a new male contraceptive. It's a gel. It's in clinical trial, but you're going to learn more about the contraceptive. You'll also learn how you can participate in the clinical trial if you wanted to.

This is "Who Cares About Men's Health." My name is Scot Singpiel I bring the BS. Bringing the MD to the table is Dr. Troy Madsen.

Troy: Hey, Scot.

Scot: And our guest today is Dr. David Turok. He is an OB-GYN and also a family practice physician. He is interested in family planning, and he is . . . Are you running this clinical trial? How are you involved exactly?

Dr. Turok: Yeah. I am the site lead for the Utah site, and there are 10 other sites.

Scot: All right. So, Dr. Turok, tell me about this male contraceptive gel that you're running the clinical trials on. What do we need to know?

Dr. Turok: So this is an awesome opportunity for our team and for men in Utah to make a real contribution to increasing the range of contraceptive methods that are available for people. So this is the first study that's been available for people in Utah for a male hormonal method. And this study is looking at a gel that will be applied daily on the shoulders. Literally, this study rests on the shoulders of male participants.

Scot: And what's in the gel? What's going on here?

Dr. Turok: So it's a combination of progestin or progestogen called nestorone and testosterone. And the way this stuff works is very similar to the way the birth control pill or the patch or the ring work in female contraception. Basically, this outside hormone tricks your brain into not producing the sex hormones. In women, it prevents ovulation, and in men, it prevents sperm production. It also prevents testosterone production, and that's why the gel also has some testosterone as add-back.

Troy: Interesting. So it's going to actually maybe drop your body's production of testosterone, but not necessarily affect your body's level of testosterone?

Dr. Turok: Correct. That's the goal.

Scot: Yeah. Okay. Explain that. I'm not buying into this quite yet. What did you just say, Troy?

Troy: I'll let David explain it. I'm guessing.

Scot: I would think a lot of men would be like, "Oh, I don't know about putting something on that's going to decrease my body's level of testosterone." That didn't sound like a great idea.

Dr. Turok: Right. For decades, we've been willing to have millions and millions of women across the globe use methods that interfere with their normal hormonal cycle in ways that are safe and effective. And this is similar to that.

So the bottom line on this is there's messaging from the brain at two levels in the brain for gonadotropin-releasing hormone, and then for FSH and LH in the pituitary. And those sex hormones trigger the production . . . There are two groups of cells in the testes that are affected by those. And getting these hormones from the outside, as application of the gel will produce, essentially deactivates one group of cells that makes sperm and the other group of cells that makes testosterone among other things.

And at that point, in order to avoid side effects that people would not like, the testosterone in the gel essentially adds back what you need.

Scot: Obviously, I'm the one without the MD, so you're going to have to explain this to me a couple of times. But we've done previous shows where we've talked about men who take testosterone, and it can cause side effects like testicle shrinkage and other sorts of things. What is preventing this from causing those types of side effects of taking artificial testosterone?

Dr. Turok: First of all, it's dosing. There likely will be some decrease in the size of the testicles. Not as much as people who are using high levels, for example, of injectable testosterone. And the other side effects are . . . There are some minor cholesterol changes with decreases in HDL. There's maybe a slight bump that can happen with hematocrit, the amount of red blood cells that you have circulating in your body. And the progestogen, the nestorone, can also cause a slight increase in weight.

There are very few things that are side-effect-free. But the vast majority of people who have used this combination and others like it have had very few side effects.

So, in the last large study of a combination of an injectable progestin and testosterone combination, there were fewer than 10% of people who quit the trial because of side effects. And if you compare that to studies of oral contraceptive pills in females, that's actually quite favorable. So I think we're seeing something that's headed in the right direction.

And again, we can only get the answers for newer and better methods if people are willing to participate in trials like this. And this is not just, "Hey, here's something you can try and tell us how you like it." This is a rigorously designed study that's going to have up to 400 couples in it. Everyone is going to get the same evaluation. It's going to be extremely thorough, looking at those outcomes that we talked about, pregnancy and side effects, as well as blood tests with chemistry and looking at people's blood levels of the drugs, of the hormones, of their red blood cell counts.

We're going to have enough people to really evaluate this to see if this is truly safe and effective. And the early signals are from this study and others like it that they are very favorable.

Troy: That's great. And for anyone who's listening who wants to participate, what kind of benefits . . . Obviously, a huge benefit is just contributing to science, which I'm sure you and I would agree is a great benefit. I don't know if Scot would agree.

Scot: Yeah. How much am I going to get paid?

Troy: Scot, that's what we're getting at. Is there any financial . . . Scot is like, "Where's the money? Show me the money." Is there a financial incentive to participating or any other benefits?

Dr. Turok: This is not a casual study. The demands of participants are significant and people are compensated for their time and effort and, I think, in a reasonable and generous way. But the combination reimbursement, if you go through the full trial for a couple, is over $3,000.

Scot: Is another prerequisite for the couples you're looking for couples that are open to if it doesn't work that they were planning on having children anyway? Because you're using a trial for a birth control method that you're not exactly sure of the efficacy yet. They could end up becoming pregnant, right?

Dr. Turok: That is an absolute risk. And people who are entering the study need to be willing to accept that. This is something where there's going to be very close observation. So we're going to be checking people's sperm counts regularly, every month throughout the study.

In normal use, something like that wouldn't happen. But this is something where if there ever was a problem or somebody had initially had a low sperm count and then it came back up, we would be able to identify that and ideally intervene before there was a risk of pregnancy.

And again, that coupled with the inherent relatively low risk of pregnancy makes this a safe and reasonable thing.

Scot: Is there a minimum amount of sexual intimacy? Is there a minimum amount of sex that you have to have while you're in this study?

Dr. Turok: Yeah.

Troy: Is this an additional incentive? Is that what you're trying to get at, Scot?

Scot: Maybe. I don't know.

Troy: Like, "Well, we've got to have sex at least three times a week."

Scot: "The study says so."

Troy: "The study says. This is for science."

Dr. Turok: Yeah, that is for couples to determine. But the minimum, the only requirement . . . And this is true for all contraceptive efficacy studies, not particular to this. But couples have to have at least one episode of intercourse where they're relying only on this method each month for that month to count in the efficacy data. So that's true whether we're studying an IUD or a pill or a new injection or the ring, anything.

Troy: And so hearing this, maybe someone is listening and thinking, "Well, I don't know that I want to be part of a study. I don't know that I would qualify. I don't know that I have the time to do this." But maybe they're thinking, "This sounds really cool." What do you think longer, bigger picture, if this next phase is successful, before this actually becomes a realistic option for men to use? Would you say realistically five years out before you think this would potentially be available by prescription?

Dr. Turok: Five years would be greased lightning.

Troy: So that would be a very optimistic scenario?

Dr. Turok: Yeah. In 2007, I wrote this paper that was a summary. It was called "The Quest for Better Contraception: Future Methods." And I was a young contraceptive researcher at the time and really wanted to do a landscape analysis of all the methods that were out there. And there was a section in that paper on male hormonal methods. 2007. And at the time, for that and several other things, we were like, "Yes, we're 5, maybe 10 years away." And we're still 5 or 10 years away, but we've made significant progress.

All of these things take time because the FDA wants to assure that these are truly safe and there are not going to be harms associated with newly approved medications. This certainly seems like it's on track and has great potential to deliver a safe and effective method over time that will be reversible.

And that's another aspect of the study, looking at what happens when you stop it. How long does it take for sperm counts to come back? And that hasn't been an issue in any of the male hormonal contraceptive studies. Nearly all the participants have had return to normal fertility.

Troy: So it's a ways out. If there's a guy now who's 20, maybe by the time he's 30, he could look at using this.

Scot: Well, sounds more like if there's a guy that's 20, maybe his son will be able to use it.

Dr. Turok: No, no, no.

Troy: I didn't want to go that far with it.

Scot: Troy, we're running out of time here. Do you have any final questions?

Troy: Yeah. Have you talked to anyone who's used this? And if so, what do they say about it? Do they like it? Do they find it's fairly convenient? Any personal feedback you've gotten from any participants?

Dr. Turok: Yeah. So the feedback from some other people who've participated at other sites has been extremely favorable and people have been very satisfied. The gel is easy to use. It's easy to apply. The desired results are delivered, and actually, the decrease in sperm counts is occurring a little bit faster than anticipated, which is great, but still takes two to three months. And the initial efficacy signal has been really good.

So the participants have really done a great job and have had very few concerns and negative aspects of feedback thus far, which is great.

Scot: Cool. We'll put the link to your survey site on our website. Thank you very much, Dr. Turok, and thanks for caring about men's health.


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