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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.

You've been so good about your family planning. You've always used birth control, but when can you stop? This is Dr. Kirtly Jones from Obstetrics and Gynecology here at University of Utah Health Care and this is The Scope.

So you've spent all your life planning your children. You had your babies when you wanted them. You didn't have any extra babies. You've really been good at it, but when can you stop? The answer is when you or your partner are using some form of really good birth control so you can stop. If your partner has a vasectomy, well, that's great.

Now, a really good form of birth control was menopause. So let's talk a little bit about your contraceptive method and menopause. First, fertility, we know, declines starting at about 30. We know that women who are trying to get pregnant sometimes struggle in their late 30s and certainly do in their 40s. The difficulty is that a pregnancy in your 40s that's unplanned is a definite problem because women in their 40s who get pregnant, even though they're not very fertile, do have higher risks of complications in pregnancy, like high blood pressure and diabetes.

They're actually more likely, believe it or not, to have twins. And they have more complications in terms of blood loss and a whole lot of other problems just with the pregnancy. And of course, we all worry about the difficulties in chromosomal abnormalities in our babies that increases in women after their 30s. So women are more likely to have complications in pregnancy. They are more likely to have a baby with a chromosomal anomaly like Down syndrome and importantly, they are more likely to miscarry. And by the end of your 40s, you are really likely to miscarry.

However, you don't want to get pregnant even though your chances are low. So when, even if you're being very careful, when is it time to stop? Okay. So let's now talk about menopause. Menopause is defined as when you haven't had a period for a year. Then that last period a year ago is your menopause. Now, you have to be of the right age.

So the average 20-year-old who hasn't had a period for a year is probably not in menopause. She hasn't run out of eggs. She may have another reason for not having her periods. But women in their late 40s and early 50s who haven't had a period for a year are very, very likely to be in menopause. So if you haven't had a period for a year, then you're likely in menopause and you can stop using your contraceptive method.

However, it's difficult to know if you're in menopause based on your periods if you're using a contraceptive method that changes your periods. So let's take, for example, birth control pills. Birth control pills block ovulation but give you hormones that make you have a period every month. So you can be in menopause, have no more eggs, be completely infertile, but because you're taking the pill, you'll have a period every month.

So how do you know, if you're on birth control pills, that you're in menopause? Well, the difficult answer is you have to stop your pills and see what happens. If you stop your pills, and you're about 52, and you don't have a period for six months, then you're in menopause. But what happens if you are 52, and you're still fertile, and you stop your pills, and you get pregnant? Well, the option is, of course, to stop your pills, see what happens, and use a different method, a barrier method, use condoms, use foam. Remember, you're not very likely to get pregnant because you're not very fertile and you're not very likely to stay pregnant because you're likely to miscarry. So that's one option.

The other option is to say, "Well, why don't I just stay on my pills because going through the perimenopause," those years when your periods are totally unpredictable and not very pleasant, "why don't I stay on these nice little periods that I like on the pill until I'm about 54?" We know that at 54, about 90% of women have gotten through menopause. At 50, the average age of menopause, only 50% of women are menopausal. But by 54, about 85 to 95% of women are menopausal. So you just stay on your pills and stop at 50 and you're very likely to be done.

Let's talk about an IUD that has hormones in it. For women who have an IUD with hormones in it, many of those women have very light periods or no periods at all so you may not know that you're in menopause. You may have some hot flushes because your estrogens have gone away. You may use a blood test, which doesn't work very well for women on the pill, but it can work for people with a hormone-containing IUD. You could do a blood test called FSH and if that is really high, then it's likely, not guaranteed, but likely, that you've run out of eggs and you're in menopause.

Or you can just stay on that IUD that has some hormones in it until you're about 54. And many women in their early 50s who have hot flushes may want to take a little estrogen and they have the progestin protection. They protect their uterus lining against abnormalities with that little hormonal IUD. So wait until you're a little older and then take your hormonal IUD out.

If you're taking a shot like Depo-Provera, about 80% of women on Depo-Provera don't have periods so you won't know when you're in menopause. Well, the same kind of strategy goes with Depo-Provera as it does with the hormone-containing IUD. You can just wait till you're a little older or you can stop, use a backup method. You can stop your shots, use a backup method, and wait and see if you start your periods again.

So this is kind of a complicated question. The good news is that for women who stop their method, whatever it might be, at 50, then, in fact, the chances of getting pregnant are very low. How low is low for you, though? If the chances of getting pregnant and having a baby is 50 to 1 in 100, is that a number that you're willing to take a risk for? Not me. For me, that's no, I wouldn't take a 1 in 100 risk of a baby, that with all the complications of a pregnancy at 50 is. So I was much more willing to push my contraception out to 54 and then say, "Now I'm ready to be done."

So it's a personal choice. It's one that you discuss with your partner, with your family, if that's what you want to do, in terms of what their thinking about future childbearing, what kinds of risks are they willing to take if you do get pregnant? But definitely talk with your clinician because there are some options that are really good ones to make this transition with low fertility, but still some fertility, and some good therapy for menopausal symptoms.

So many women actually use a low-dose birth control pill to help them with their menopause symptoms. So that's the difficult answer for a difficult question, but I want to say good for you for having been such a good contraceptor all these years. And thanks for joining us on The Scope.

updated: January 28, 2021
originally published: September 29, 2016

Dr. Jones: Need to get back on birth control, but don't have the time for a medical visit? There's an app for that. This is doctor Kirtly Jones from Obstetrics and Gynecology at University of Utah Health Care and this is The Scope.

Announcer: Covering all aspects of women's health. This is "The Seven Domains of Women's Health" with Dr. Kirtly Jones on The Scope.

Dr. Jones: As Internet shopping and services have grown to the limits of my credit card, I have been thinking about how long it takes to get somewhere for medical care and to find a place to park when I get there. I can use a half-day for a very short medical appointment. What should I wear? Do I have to dress up? Is there gas in the car? I better get there early and not forget my insurance card.

It's even harder for women who live far away from health care. However, UPS, FedEx and the United States Postal Service go everywhere. So why not access birth control online? If you can get Viagra online, you certainly should be able to get birth control online. So why not get your birth control online? Is it legal? Is it safe?

The change began rather quietly about 20 years ago when clinicians who do family planning did research on whether women actually needed a pelvic exam to get birth control pills. For many women, especially young women, the requirement of a pelvic exam for birth control was a barrier. Quietly, family planning clinics across the country stopped requiring a physical exam for birth control.

Women would be face-to-face with the clinician, have their blood pressure taken, and their medical history reviewed. And if they had no contraindications to birth control pills, patches or rings, they could get a prescription. Then they would go find a pharmacy, find a place to park, wait in line at the pharmacy, wait for the prescription to be filled, etc., etc.

That still required in appointment in a visit to clinics, which may not have been very accessible to some women. Women who live far from a clinic, young women without transportation, and women who are working or didn't have child care, although we've all done contraceptive visits with women who had four children in tow in the exam room and had to keep the four-year-old out of the medical equipment drawer and the two-year-old from putting the Q-tip up their nose.

Now, more clinics are using telemedicine and now there are online services where you can have an online face-to-face interview with a licensed clinician to get a prescription. Or you can fill out a questionnaire that is reviewed by a clinician, you might say, "But you can lie about your age or your medical history." Well, but of course, you can do that in-person as well. Some websites will take insurance. Some will deliver the prescription to your home. Recently, the New York Times published an online app for you to choose which online birth control app you might want. The Scope Radio website can direct you to that app or you can Google "New York Times interactive birth control options apps."

Of course, you cannot access the most effective methods of reversible contraception online, IUDs and implants. You have to go to a clinic to have those placed. And all birth control methods have some risks. You could have a latex allergy to the condoms that you ordered on Amazon. Yes, Amazon has over-the-counter contraception, including emergency contraception. But remember that emergency contraception's should be taken as soon as possible within 72 hours of the unprotected sex and best within 48 hours. Unless the delivery drone has your home in sight, it won't get to your house in the time that you should use it.

Hormonal contraception has some risks and women should be knowledgeable about those risks, but they're the same if you drove to the clinic and waited for an appointment or if you had the interview online. The most important issue is to give options to women who have limited access for some reason and to allow every child to be planned and wanted.

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