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Transcribed by AI. May contain errors.

 

Music 

Yo, I don't think we should talk about this. People might misunderstand what we trying to say.

 

Amy Quinton 

Why are you playing Salt-N-Pepa? Is this "Let's Talk About Sex?"

 

Marianne Russ Sharp 

Oh, you really know your 90s hip hop Amy?

 

Amy Quinton 

Wait a minute, are we going to be talking about sex?

 

Marianne Russ Sharp 

You're very astute. Yes, indeed we will be. This episode is about birth control. And this is also a good time for us to let people know that this may not be suitable for all audiences, especially the youngest listeners.

 

Amy Quinton 

All right, birth control things like condoms, birth control pills, IUDs, implants and shots.

 

Marianne Russ Sharp 

And with the exception of condoms, all those methods you named are for women. But in this episode, we're going to be talking about reversible hormonal birth control for men.

 

Amy Quinton 

Finally,

 

Marianne Russ Sharp 

Here, here.

 

Amy Quinton 

You must be talking about the clinical trial taking place at °ÄÃÅÁùºÏ²Ê×ÊÁÏ¿â Davis Health, the one funded by the National Institutes of Health.

 

Marianne Russ Sharp 

That's right. They're testing a hormonal gel that the man rubs on to his shoulders. It was developed by the Population Council and studies are being conducted by the NIH.

 

Amy Quinton 

We're going to tell you all about the trial including a very frank conversation with a couple taking part in it in this episode of Unfold.

 

Amy Quinton 

Coming to you from °ÄÃÅÁùºÏ²Ê×ÊÁÏ¿â Davis and °ÄÃÅÁùºÏ²Ê×ÊÁÏ¿â Davis Health, this is Unfold. I'm Amy Quinton

 

Marianne Russ Sharp 

And I'm Marianne Russ Sharp.

 

Amy Quinton 

Before we get into male hormonal birth control, it's a good idea to get a quick refresher on how female hormonal birth control works. Take the pill, for example. I mean, don't actually take it, but as an example.

 

Marianne Russ Sharp 

Yes, we got you. Dr. Mitchell Creinin is a professor of obstetrics and gynecology and a Family Planning Specialist at °ÄÃÅÁùºÏ²Ê×ÊÁÏ¿â Davis Health.

 

Dr. Mitchell Creinin 

When a woman takes a combined birth control pill there's two hormones and estrogen and progestin. And so it's the progestin that really works to prevent pregnancy, it shuts down the system, so the brain no longer tells the ovary to work.

 

Marianne Russ Sharp 

And when the ovary stops working. It not only stops making eggs. . .

 

Dr. Mitchell Creinin 

But it also stops making hormones. So for the woman to feel normal, we have to give her the estrogen back.

 

Amy Quinton 

Dr. Creinin, who is running the clinical trial at °ÄÃÅÁùºÏ²Ê×ÊÁÏ¿â Davis says the hormonal contraception gel for men works in a similar way.

 

Dr. Mitchell Creinin 

We're giving a progestin called Nestorone in a gel, the brain stops telling the testes to work so it no longer makes sperm but it also doesn't make testosterone and for a man to feel normal and have erections and even be able to have sex, he needs testosterone, so we give them Nestorone plus testosterone, whereas a woman is getting a progestin plus estrogen, same kind of process.

 

Amy Quinton 

Okay, so that's how it works. Marianne, we mentioned that this is a clinical trial. So tell me a little bit more about that.

 

Marianne Russ Sharp 

Okay, so we should first point out that the trial is taking place all over the world, not just at °ÄÃÅÁùºÏ²Ê×ÊÁÏ¿â Davis. Right now, Dr. Creinin says they're about three years into the phase two trial, the human testing phase, they're not currently recruiting. They had a lot of interest and people signed up quickly.

 

Amy Quinton 

Good. So is it working?

 

Marianne Russ Sharp 

Dr. Creinin says it's working even better than expected. Most couples have had minimal or manageable side effects.

 

Amy Quinton 

I imagine it is a big decision to take part in this trial, regardless of potential side effects. Right? 

 

Marianne Russ Sharp 

It is. And I found a couple taking part in the trial who were willing to let me into their home to ask some pretty personal questions.

 

Marianne Russ Sharp 

On a recent Sunday morning, I visited Matthew Treviño and Emily Fletcher at their home in a quiet Sacramento neighborhood. Matthew is 35. Emily is 28. And they both work at °ÄÃÅÁùºÏ²Ê×ÊÁÏ¿â Davis. In fact, that's where they met.

 

Matthew °Õ°ù±ð±¹¾±Ã±´Ç&²Ô²ú²õ±è;

She caught my eye walking into work one day as a new employee. And she caught me staring at her walking away from me. So yeah, and it kind of was awkward at first. It

 

Emily Fletcher 

It sure was, because I turned around and I was like, Hello. Who are you? Man staring at me.

 

Marianne Russ Sharp 

It was an awkward, funny encounter. But that's not so unusual for Matthew, who actually spend time as a stand up comedian. He's really funny. Emily says that's one of the many things that makes him so much fun to be around.

 

Emily Fletcher 

He just makes me really happy anytime we're together. And I think I realized that maybe like two or three months in I think I think I'm going to stick with this one.

 

Marianne Russ Sharp 

Matthew knew almost right away that he was in love with Emily. He even blurted it out in this moment of spontaneity during a weekend getaway. But get this. Emily didn't hear him. He was pretty relieved. And a few months later on a trip to Point Reyes, he said it again.

 

Matthew °Õ°ù±ð±¹¾±Ã±´Ç&²Ô²ú²õ±è;

And like, whales were jumping, there was elk everywhere. There's like wildflower blooms and all this other stuff and, and then I said it to make sure that she could hear me.

 

Marianne Russ Sharp 

She said it back.

 

Matthew °Õ°ù±ð±¹¾±Ã±´Ç&²Ô²ú²õ±è;

And that was that was probably the beginning of when we were both like, Yeah, we're gonna be around for a while. bajillion years, give or take,

 

Emily Fletcher 

That's usually what we say

 

Amy Quinton 

A bajillion years, they have such a great love story. How long have they been together?

 

Marianne Russ Sharp 

They're awesome. They've been a couple for more than three years and have been living together for more than two of those. And by the way, that's important because to take part in the trial, a couple has to be in a committed relationship.

 

Amy Quinton 

So how did Matthew and Emily find out about this trial in the first place?

 

Marianne Russ Sharp 

Well, a friend sent Matthew some information about the trial, which was also taking place in Portland. So he called the Portland site, and they steered him to °ÄÃÅÁùºÏ²Ê×ÊÁÏ¿â Davis. Matthew is a researcher at heart. And he says he's really driven by data. So he was intrigued.

 

Matthew °Õ°ù±ð±¹¾±Ã±´Ç&²Ô²ú²õ±è;

I've always been interested in male contraception. I kind of think it's unfair, that it's only lands on the women. And a guy can get a girl pregnant every day throughout the year, but a woman can only have one pregnancy throughout the year. So it's like maybe, maybe the burden is on the wrong side.

 

Amy Quinton 

Yeah, maybe the burden is on the wrong side. But what about Emily? Was she on board right away, too?

 

Marianne Russ Sharp 

It was a little more complicated for Emily. She had been on some form of birth control for a long time, and she was on an IUD and would have to go off that for them to take part.

 

Emily Fletcher 

I had been on birth control since I was 12. As soon as my, my cycle started, it was just uncontrollable, and I was anemic. I wasn't having a normal life. So they decided the best way to do it was to just put me on birth control. Um, so that was 15 years of hormones in my body that I had never let normalize.

 

Amy Quinton 

You know, it's not just about a woman's health, either. There's a lot to consider with this, especially given the changing laws around abortion access.

 

Marianne Russ Sharp 

Yeah. And Emily had some of those concerns.

 

Emily Fletcher 

I was worried about getting off of my birth control. Mostly because at the time that we were just introducing ourselves to the study was when all of the Roe v Wade, and abortion stuff was happening. And knowing that we live in California, I was less concerned than if I lived somewhere else. But it was still a thought in the back of my mind that maybe this will be an issue like if the drug doesn't work, and I get pregnant.

 

Marianne Russ Sharp 

In the end, Emily decided it was the right thing for her and for their relationship. And as Matthew says, there's another factor that plays into this for both of them.

 

Matthew °Õ°ù±ð±¹¾±Ã±´Ç&²Ô²ú²õ±è;

I've never really had that, like, urge to be a parent. And luckily, we're kind of in a time now that adults choosing not to be parents is becoming more and more accepted. There's a term we've learned in the last month DINK, which is double income, no kids. And then there's also DINKWAD, double income, no kids, with a dog. And we are 100% DINKWADS.

 

Matthew °Õ°ù±ð±¹¾±Ã±´Ç&²Ô²ú²õ±è;

Hey. You gonna lay down right here. Come right here. Come on. Oh, you cutie. You cutie dog.

 

Amy Quinton 

I thought that that was a dog I was hearing.

 

Marianne Russ Sharp 

You're good. Yeah, the sweetest dog. She's a rescue. Her name is Rosie. And we have an adorable family portrait of the three of them on our website, ucdavis.edu/unfold. Definitely check it out.

 

Amy Quinton 

So what does the trial mean for them in terms of like their everyday life, their routine?

 

Marianne Russ Sharp 

Well, that's the next part of the story.

 

Matthew °Õ°ù±ð±¹¾±Ã±´Ç&²Ô²ú²õ±è;

So this is the actual drug.

 

Marianne Russ Sharp 

Matthew standing in front of his bathroom mirror with his shirt off. He's a former Marine and has colorful tattoos covering his left arm. Most are symbols of California like the state capitol building redwood trees and Mount Shasta. Every morning for the last year, this is where he's applied the gel. It comes in a canister about the size of a can of shaving cream, and each one holds two weeks worth of doses.

 

Matthew °Õ°ù±ð±¹¾±Ã±´Ç&²Ô²ú²õ±è;

And it's just become a part of my morning routine. Like wake up, use the bathroom, brush my teeth and then apply 74 milligrams and half of that per squirt. So one squirt in one hand goes to one side of the chest, and then the other squirt goes to the other side. So it's really quick, it's alcohol based. So it evaporates pretty fast. Get all the tattoos. And that's pretty much it. And then wash hands afterwards, They want us like no contact with your partner for four hours after application. Just so Emily doesn't get any of the testosterone or the drug on her. And then just go about my day after that, it's super easy. Not really like an inconvenience to the day or anything like that. And yeah.

 

Marianne Russ Sharp 

Side effects are possible with the drug. But for Matthew, they've been minimal, and not all necessarily negative.

 

Matthew °Õ°ù±ð±¹¾±Ã±´Ç&²Ô²ú²õ±è;

I've only experienced increased libido, probably some weight gain, I mean, and my case could be unique. There's there's hundreds of couples that are going through this. Some may have you know, decreased libido, everybody's body is going to react differently to a new drug.

 

Marianne Russ Sharp 

The list of possible side effects from the drug as long it includes things like dry or oily skin increased or decreased libido, hair growth or loss, mood swings, and more.

 

Matthew °Õ°ù±ð±¹¾±Ã±´Ç&²Ô²ú²õ±è;

Maybe I'm just lucking out. But I hope this is the case for the majority of participants. Because if that is the case, then there's there's something we have on our hands here that is definitely going to change contraception as a whole. I feel

 

Marianne Russ Sharp 

Emily says she's had no major issues from going off her birth control. And they both say the trial has affected their sex life.

 

Matthew °Õ°ù±ð±¹¾±Ã±´Ç&²Ô²ú²õ±è;

There are periods where before I go in for an appointment, they they want me to refrain from ejaculations for two to seven days. And it's like we're always pushing the to two to three day mark. You're not gonna get seven days out of us. But it's even in those two, three days. Like she can attest, like I'm chomping at the bit. It's just like, come on, is it time? Can we can we do something now?

 

Emily Fletcher 

Yeah, I was gonna say I've had to adjust. But we definitely I think are having more sex now than we did before.

 

Matthew °Õ°ù±ð±¹¾±Ã±´Ç&²Ô²ú²õ±è;

With less worry.

 

Emily Fletcher 

Yeah, that's with less worry. The IUD is really effective, but knowing that his sperm count is essentially zero. It's definitely you know, it's peace of mind.

 

Amy Quinton 

It really is peace of mind to know that it's effective for them. A sperm count of zero? Wow. Yeah.

 

Marianne Russ Sharp 

And Emily went off her IUD without any negative health issues. They've had a great experience.

 

Amy Quinton 

So there must be more than just applying the gel every day since researchers are testing this new drug right? So what are the other requirements of the trial for Matthew and Emily like do they have regular checkups?

 

Marianne Russ Sharp 

Yeah, they do. In fact, I tagged along for one of Matthews appointments recently and °ÄÃÅÁùºÏ²Ê×ÊÁÏ¿â Davis Health. It included tests that are part of the study.

 

Edward Elizarraras 

Alright, let me go ahead and take your vitals.

 

Marianne Russ Sharp 

Matthew is sitting in a chair in an exam room while Edward Elizarraras, a clinical research coordinator takes his blood pressure. Elizarraras this also accepts the semen sample from Matthew that he collected at home and give some of the results from last month.

 

Edward Elizarraras 

Your sperm count was still at zero which is good perfect. And then your labs last visit we did a hemoglobin hematocrit that came out in normal as well today we'll do...

 

Marianne Russ Sharp 

Elizarraras prepares to take more blood to run a metabolic panel a complete blood count, and check Matthew's hormone levels to make sure everything's normal.

 

Edward Elizarraras 

Now let me go ahead and draw your blood.

 

Marianne Russ Sharp 

Matthew also turns in a log of each time he's applied the gel and diaries that he and Emily keep about their sex life and any side effects and he gets two new canisters of the gel.

 

Edward Elizarraras 

If you have any questions, just let us know. And then we'll see you next month. Yep.

 

Amy Quinton 

So Matthew has monthly medical appointments. What is Emily have to do?

 

Marianne Russ Sharp 

Well, in addition to the diary, Emily also has regular check ins with the trial staff, not quite as often as Matthew,

 

Amy Quinton 

I loved hearing from Matthew and Emily. But one thing we didn't talk about was how quickly the gel works. Dr. Creinin says this is an area where things work differently than with female hormonal birth control.

 

Dr. Mitchell Creinin 

We are used to a birth control pill for a woman where she can start it and it starts right away. And then she can stop it and she can get pregnant right away. A man's system is not set up that way.

 

Marianne Russ Sharp 

Dr. Creinin says sperm production will shut down and start back up. But because men are normally making sperm all the time, the timing is different.

 

Dr. Mitchell Creinin 

You have to have a large volume of sperm for in the ejaculate for pregnancy to occur. So it takes a while to get the numbers down. And then afterwards, it takes a few months to get the numbers back up.

 

Amy Quinton 

The time commitment for a couple to take part in the trial is nearly two years, including a full year of it being the sole form of contraception. And a few months on either side, as things ramp up and then down,

 

Marianne Russ Sharp 

Researchers expected the gel to work about as well as the female birth control pill. And it's working even better than they expected.

 

Amy Quinton 

That's great. So what's next for Matthew and Emily?

 

Marianne Russ Sharp 

Matthew and Emily have been in the trial now for more than a year, and they're in what's called the recovery phase, which means he's off the gel. And within a few months, they expect his sperm count to be back to normal.

 

Amy Quinton 

They had a tough choice about birth control again, then huh?

 

Marianne Russ Sharp 

Yeah, they are back to using condoms. And Matthew is now thinking about a vasectomy. There's also the possibility of enrolling in phase three of the trial.

 

Amy Quinton 

Oh, there's a phase three. I didn't know that.

 

Marianne Russ Sharp 

Yeah, researchers are still planning that. And it would include a lot more people, they hope they'll be able to start enrolling participants maybe next year or in 2025.

 

Amy Quinton 

I don't suppose Matthew and Emily could keep using the gel until then?

 

Marianne Russ Sharp 

Oh, they wish they could. But unfortunately not, it is all very tightly controlled. Since it is a clinical trial. They did both say they would buy it right now if they could.

 

Amy Quinton 

And Dr. Creinin says they're hoping to be able to publish some of the study's findings in the coming year. He thinks this trial is a turning point.

 

Dr. Mitchell Creinin 

I think that this first product that comes to market and this probably will be that first product, whenever it happens, is going to create a social change the way our society thinks about couples and men's and women's responsibility for preventing pregnancy, not that it will shift it away from women. But it will make all of us realize that both truly need to participate.

 

Marianne Russ Sharp 

That's definitely also how Matthew feels about it. And Dr. Creinin takes it a step further.

 

Dr. Mitchell Creinin 

But I think we also need to change the way we're approaching women and protecting them. And realizing that our greatest resource is not a man with testicles are our greatest resource are women in our society. And none of us would be here without the women that went through pregnancy for us.

 

Amy Quinton 

I couldn't have said it better myself. And Dr. Creinin really is optimistic about the possibilities.

 

Dr. Mitchell Creinin 

I've been doing contraceptive development studies for over 30 years. And I never thought in my lifetime, that we'd be getting this close with male hormonal contraception. It's the kind of thing that might keep me from retiring. I wanted to keep seeing this to the end.

 

Marianne Russ Sharp 

Well that seems like a pretty good place to end this episode.

 

Amy Quinton 

Don't forget to visit our website where we have fantastic photos of Matthew, Emily and their dog Rosie too and you can find out more information about the clinical trial, which as a reminder is not currently enrolling people.

 

Marianne Russ Sharp 

That's right. Those pictures are beautiful. It's ucdavis.edu/unfold. And you can also listen to episodes from previous seasons of Unfold there.

 

Amy Quinton 

And don't forget to help our audience grow by subscribing to Unfold wherever you get your podcasts. So you never miss an episode. I'm Amy Quinton.

 

Marianne Russ Sharp 

And I'm Marianne Russ Sharp. Thanks for listening.

 

Amy Quinton 

Unfold is a production of °ÄÃÅÁùºÏ²Ê×ÊÁÏ¿â Davis. Original Music for Unfold comes from Damien Verrett and Curtis Jerome Haynes. Additional music comes from Blue Dot Sessions.

 

Matthew Treviño dedicates this episode to his grandfather, Hilario Treviño, or Pops. He did research as a doctor before settling on orthopedic surgery. Pops was a true Renaissance man, an artist, inventor, musician, poet and ran his own practice. He was and still is a big inspiration to Matthew and why he became interested in research. He is the reason Matthew is the man he is today.