Search for tag: "u0168735"

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

This content was originally created for audio. Some elements such as tone, sound effects, and music can be hard to translate to text. As such, the following is a summary of the episode and has been edited for clarity. For the full experience, we encourage you to subscribe and listen— it's more fun that way.

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.

Dr. Jones: So you ran out of your birth control pills and the condom broke or something like that. You really don't want to get pregnant right now or anytime soon. What do we know about your options?

Many women know about emergency contraception, and many don't, something you can do to decrease your chance of pregnancy if you had unprotected or under-protected intercourse. There are two types of emergency contraceptions approved by the FDA that are available in the U.S., and they are pills, and they decrease the chance of pregnancy if they're taken within five days of unprotected intercourse. But there are other types of birth control that would work and keep on working if you're looking for contraception for more than this month.

With us today is Dr. David Turok. He is an OB/GYN specialist in family planning and chief of the division of family planning at the University of Utah. Thanks for taking some time for us, Dr. Turok.

Dr. Turok: Thank you.

Dr. Jones: What were the background reasons to ask the question of whether the levonorgestrel IUD, which is what we're going to be talking about, would work for emergency contraception? What made you do this question?

Dr. Turok: Well, I speak with people a lot about emergency contraception because I'm very interested in it, and I think it's amazing that you can use something after you've had sex to prevent pregnancy. And every time I talk about it with people during grand rounds or during educational presentations, people always, always, always ask . . . because we know we have great data to say that the copper IUD works very well for emergency contraception, people always ask, "Well, what about the hormonal IUD, the levonorgestrel IUD? Can you use that?" So 10 years ago, we started trying to gather data on this topic, and finally we have an answer.

Dr. Jones: So people came to the clinic wanting emergency contraception and they walked into the clinic thinking that they might get some pills. How did you get so many women to participate in the study when they came for just pills?

Dr. Turok: Like in many aspects of life, Utah is unique. And currently, one of the forms of emergency contraception pills is available without a prescription. You can just walk into pharmacy or supermarket and get them. Sometimes it's behind the counter, you might have to ask, but you can get it without a prescription.

In Utah, because there are many limitations for people, young people especially, with insurance coverage, people seek out the cheapest place to get it, and that is Planned Parenthood where there's a sliding scale and where people have known for a long time that they can get the pills.

And we've done a few different surveys and a few different kinds of projects where we offer people walking in for emergency contraception IUDs, and it's around 12ish percent of people are interested in an IUD in that setting. And that's, I think, potentially driven in Utah by the fact that people don't have adequate insurance coverage and they're looking for opportunities to get better methods of contraception. And when there are low or no-cost options presented, people are interested.

So, at the peak before Plan B, one of the pills was available over the counter. Planned Parenthood statewide distributed more than 50,000 doses of oral emergency contraception. So people know, and lots of people come to Planned Parenthood clinics in our state for the service, and when you present them with IUDs, some are interested in it.

Dr. Jones: So some of them are really looking for something for longer than just this month?

Dr. Turok: Exactly. Yes.

Dr. Jones: Right. So you've known that the copper IUD . . . we've all known from data that goes back 20 years, really, that the copper IUD works. So you then offered them either a copper IUD or a hormone-containing IUD. And what did you discover?

Dr. Turok: So what we found in this study where we randomized people to get one or the other type of IUD, either copper or the hormonal IUD, we found that the pregnancy rate was low, very low, in both groups in the month after.

So with copper IUDs, we had 321 people who were assigned to that, and we got one-month outcome data on. And we expected in that group, zero or one would have a pregnancy. And it was zero.

And with the levonorgestrel group, we really didn't know. We had built into the study stopping points. Like, if there were a bunch of pregnancies early on, we were just going to stop. But what happened was there were 317 people who got the levonorgestrel IUD and there was one pregnancy. Lower than we thought and much better than the pills.

Dr. Jones: Right. That's important because the methods that are currently FDA-approved, that those 50,000 women who came to our clinics seeking pills, the failure rate or the ineffectiveness rate is much higher than what you found with the IUDs, either one of them.

Dr. Turok: Yeah. To me, one of the very cool things about the study is the other studies that got FDA approval for those oral methods, these were things that took a long time and hundreds of millions of dollars were spent to go through the FDA process to get that approval. And in this study, we took a method that was already FDA-approved and we just showed that it works for this as well.

And the upside relative to the pills is, as you know, that people who are getting this can get . . . this is not just better than the pills for this one event, but you can continue to use it as long as you want, up to seven years, or for the copper IUD, up to 12 years. And that is a set-it-and-forget-it method.

Then for the LNG IUD, there's this side benefit, which is why it's more popular than, I think, the copper IUD, in that it dramatically reduces or eliminates both menstrual bleeding and cramping. And that is a big upside. And that's why I think people really wanted an answer to this.

Dr. Jones: Well, we have some evidence from another big study that just gave women what they wanted when they asked for contraception and then followed them, that the IUDs were something like 20 times more effective than birth control pills in preventing pregnancy?

Dr. Turok: Correct.

Dr. Jones: So if a woman comes to our clinic for an emergency contraception and she wants long-term reliable contraception, would she be offered an IUD, do you think, in our clinics? Because now that the work was done around here, I'm hoping that our clinicians know that it's an option. Do you think it's going to be used in the clinics?

Dr. Turok: I want to say absolutely.

Dr. Jones: I do, too.

Dr. Turok: But I would also say as our team is working on getting this paper published, I would occasionally have these pangs of terrible thoughts that 10 years down the road, it's going to be like the authors of this paper and 10 other people that we know that know about this and nobody is going to ever have done any of it.

And so I started making lots of phone calls and sending lots of emails to people who I thought would be critical partners in disseminating the information. And one of the things that helps get the word out a lot is getting the paper published in a high-impact journal.

Dr. Jones: Right. It was published in "The New England Journal of Medicine," which is probably our premier medical research journal, I think, in the United States, or one of them.

Dr. Turok: One of the, I think, nice things about the study is "The New England Journal" publishes papers that change practice. That is their main motivator for selecting research articles. And you have a very low chance of submitting something and getting it published. But it was very reassuring to know that they felt this was important enough to be published there and that they were confident that it would change practice.

And there are lots of other organizations, professional organizations, a variety of health practitioners, and providers that can disseminate this to people who work with them.

I also have been working with the people from UpToDate to revise the article on emergency contraception to incorporate this and they were amazing. ACOG carried a piece on their listserv email and we're going to work with them to try to update Lark information in their emergency contraception information. So there are all kinds of ways to get the information out.

And a really important place to do that is also with Planned Parenthood Federation of America. As you know, they have something called the National Medical Committee that makes decisions on changes in practice. So I just sent an email and lately before this interview responding to questions from people who organize the National Medical Committee about this.

It's, I think, a great opportunity for Planned Parenthood Federation of America to lead on the dissemination of this because the information came exclusively from Planned Parenthood clinics. This is a collaboration between our team at the University of Utah and Planned Parenthood Association of Utah.

If you look at what gets published in "The New England Journal," the vast majority . . . and currently, probably nobody is a more fastidious reader and consumer of their publication than you. If you look at those trials that get published, most of them are these big, multi-site, and sometimes multinational studies with tons of sites and huge numbers of participants. This study is different.

Dr. Jones: It is. It's really amazing that you have a very local group who was completely committed to answering the question. And I think that that's a phenomenal thing.

I think, at The Scope, we're trying to get the word out also to individual women so they might be willing to come in and ask. So not only do clinicians need to know, but if individual women say, "By the way, do you think I could get this IUD today? Do I have to wait?" that changes practice.

Dr. Turok: Absolutely. So the education and dissemination of information have to be from push and pull factors from supply and demand side. And as I had mentioned, we're already working on trying to get providers up to speed. But there's lots of opportunity that we're going to be working on to make sure that people who are seeking emergency contraception will know about this.

Obviously, the internet is a fabulous place to do that. And there are also some organizations that focus specifically on emergency contraception. There's a U.S. Emergency Contraception Consortium and an International Consortium of Emergency Contraception, and they are fabulous at providing consumers information about different products and ways to access them. So we look forward to working with them as well.

Dr. Jones: Right. Well, Dr. Turok, I am very grateful for your time, and we'll work at The Scope in trying to get people the information they need. But the research to answer this kind of question takes years and takes a team of dozens of nurses, and clinic staff, and researchers, and above all, it takes hundreds of women who are willing to participate, answer questions, and follow up. To all of them, we are very grateful because "I hope I just didn't get pregnant" isn't a very good birth control method. And it's been a long time coming and I'm so glad to see it here. Thanks a lot, and thanks for joining us on The Scope.

Dr. Jones: What would the life of women and their children look like if every woman had the information and ability to plan every pregnancy? This is Dr. 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: In the United States, almost half of all pregnancies are unplanned. In about half of those, the unplanned pregnancies were mistimed and about one-half of those pregnancies were unwanted. What would happen in the lives of women if they had all the information they needed to make a careful decision about pregnancy, or contraception, and they could get any method of contraception they wanted for free? Dr. Turok is a clinical professor in the Department of Obstetrics and Gynecology here at the University of Utah and a specialist of family planning.

Welcome, Dr. Turok. What happens in young women's lives when they have an unplanned pregnancy?

Dr. Turok: The largest group of women who have abortions in this country are those who have unintended pregnancies and as you mentioned, it a lot of people. It's over a million women a year. And for women who continue with a pregnancy, pregnancy is a chaotic time, as is child rearing, and if you're not planning for it from the get go, it further complicates things.

A population of people who have had planned pregnancies and a population of people who have had unplanned pregnancies and the children thereof, the kids from unplanned pregnancies are more likely to be born premature, to end up in the newborn ICU, to have less medical care in their first year of life, to do less well in school, and to not finish school.

Dr. Jones: So there are good reasons to build a structure around which families can be planned. We all want the kids that come to us, we don't all, but most of us want the kids that came to us because we, after the fact, create this incredible story about our kid was the miracle we didn't planned, but we love. But there are consequences to having babies that aren't planned.

Dr. Turok: There certainly are. The best predictor of having loving parents around to care for a child is to have been planning for that child from the beginning. And it's such an important predictor of how well children do that anything that we can do to help people time their pregnancies so they end up with the children they want, when they want them, only helps everybody.

Dr. Jones: In other countries, I know Europe does a pretty does a good job, people in Scandinavia do a pretty good job planning their children. What's keeping us in the U.S. from planning our children? Why do we have the highest rate of unplanned pregnancies in the Western world?

Dr. Turok: The difference between Scandinavia and the United States are many things. It's sexuality education, it's the conversations that children and young people and their parents have regarding the expectations for intimate partners. And it's the availability of contraception. In Scandinavia many more women use the most effective, reversible methods of contraception like IUD's and implants. And what we've seen in the United States in the past decade is that as communities and states have broadened the availability of these most effective methods, the rates of unintended pregnancy and abortion have plummeted.

Dr. Jones: What is it about America? Is it that we are a multicultural country? Because we don't have a unified healthcare system? Is it because we have diversity in income across the country? We have people who are truly poor. Why are we different than the Scandinavians, other than we don't have as many blonde people?

Dr. Turok: The biggest thing we see in disparities of unintended pregnancy are along socioeconomic lines, and race and class, and women of color, women who have completed less education, women who have fewer financial resources, are much more likely to have unintended pregnancies. In making opposites available and really removing all barriers to obtain methods of contraception will aid those people in determining when and if they have children.

Dr. Jones: We still have to reach out though to women. Women have to be thinking about contraception rather than just saying "oops", or, This is just what happens to me, and it happened to my mother and it happened to my sister." So how are we going to reach out to a vulnerable population of women here in Utah, here in Salt Lake County, to get their attention and say, "Are you sexually active?" Or whatever that means. "Do you want contraception? Do you want it for free? Come and see us." How are we going to reach out to the people who don't think they're going to get pregnant?

Dr. Turok: We've been working on this for quite some time, and the number one place people who want to initiate contraception, who have barrier of obtaining it come to in Salt Lake County is Planned Parenthood. So that's why we are collaborating with the four Planned Parenthood clinics in Salt Lake County to provide any method of contraception that women want that's offered at those clinics for free. And that includes the most expensive and the most effective methods, which are IUD's and implants.

Dr. Jones: And women who come in, they can get their method for free, but some of them actually might be willing to let us contact them in the years to come to see what happened with their lives using whatever method they chose.

Dr. Turok: Right. So we've started this project called "HER Salt Lake," or the HER Salt Lake Contraceptive Initiative, and what it does is we have three six-month periods. The first period is just the way it has been for very long, where people essentially have to figure out how they're going to get their method and pay for it.

The second period we eliminate all the costs. You walk in, you get the method you want, regardless of the ability to pay. And you don't pay anything.

And the third six-month period, we have a media campaign where women 18-29 years old will receive information on they had held devices that promotes the information about IUD's and implants and connects them with the places where they can get it for free. It'll be on Facebook, it'll be on Twitter, but it'll also be on pop up ads. It'll be modulated along the way to optimize the message and the way people receive it and when they get it. It requires a lot of community support, and support from outside resources, but we can get this done and we're working on creating a durable solution for this.

Dr. Jones: Years ago we had a picture of a pie which looked at the pregnancy outcomes in this country with the unplanned rate at a little over 50%, and for years and years that didn't budge, and you told me that your life's work was going to be to move the needle. How do you think it's going?

Dr. Turok: Yeah I think what I said was, if the shape of the pie doesn't change during the course of my work life, I'm going to be really upset that I didn't spend enough time skiing with my kids.

Dr. Jones: Dr. Turok, thanks for joining us and thank you for moving the slice of the pie that will be afforded to children who've been planned.

Announcer: TheScopeRadio.com is University of Utah Health Science's radio. If you like what you heard, be sure to get our latest content by following us on Facebook, just click on the Facebook icon on TheScopeRadio.com.