Transcript
A (0:10)
Gotta stop being cute. Same thing with periods. Too cute about those periods. That's not even the right name for it. All the names for periods suck. Period, time of the month, Aunt Flo. They all suck. You know what you call a period? A period should be called bloody tissue falling out of a hole. If you went into work and you were like, hey, I got bloody tissue falling out of a hall, they'd be like, yeah, take the week.
B (0:49)
So that was a comedian on the names of things, medical things, specifically for women's health. She says, guys, please stop being cute with this, oh my gosh, I'm sorry, and Flo. Anyway, all these little nicknames that we have for, for a period. She says it really should be called bloody tissue coming out of a hole. I'm sorry. It's kind of crude, but kind of funny at the same time. And I've said many times before, guys, trust me, I'm going somewhere. As we lead into this episode. I mean, while I love being a women's health care provider, I really am amazed at ability and capacity of a woman. I mean, my goodness, I'm telling you, I've had a man cold, which I've had recently, if you listen to the last several episodes. And for me, like the world shifts on its axis when I get a viral syndrome. Okay, I get that, I get it, Sorry. It's just the truth. So the ability for women to go through life, work, take care of children, take care of their job, go to school, whatever, with bloody tissue coming out of a hole is just mind blowing to me. So much respect to the fair sex because women, you really do have a superpower. So having said that, it is loosely connected to what we're talking about because once somebody gets on contraception, especially what we bill as or sell as, so to speak, though we're not selling, you know, per se, as we sell an agent to a patient as, hey, this is the most effective form of contraception, which it is, there's no question. Eternorgestrel, the implant is without doubt the most failure resistant method of all hormonal, reversible birth control. Without doubt. It beats Mirena, it beats the copper tea. It's phenomenal. Not a sponsor. So as we sell that to a patient in her best interest, hey, it's user free. It works phenomenal. Like a true typical failure rate of 0.505. That's actually in the data. 0.05. We've covered that in the past. It's remarkable. Not that, you know, nothing's 100% but this is pretty darn close to zero at 0.05%. So they're like, great, I love it. And we're like, hey, by the way, it also controls your periods. Eventually you just got to get through the first three to six months because bleeding will be on and off. So we're like, woohoo, I got it. But then bloody tissue starts coming out of their vagina because they get what is called breakthrough bleeding. Now even that has a weird name and association. Breakthrough bleeding. Well what is it breaking through? Well, it's breaking through endometrial suppression. That's why it's called breakthrough bleeding, which all forms of contraception can cause. Another term for this has been CI. Cimc. That's a fancier way of saying contraceptive induced menstrual changes. Well, I don't really like that because it's not really menstrual per se, because it's not part of menses. It's all related to birth control. So I do prefer BTB be breakthrough bleeding as opposed to cimc. But whatever. People use different terms. Contraceptive induced menstrual changes or breakthrough bleed. This episode, if you can't figure out what we're talking about, has to do with weird bleeding, which is annoying. Which is the number one reason why women discontinue the most effective type of reversible contraceptive hormonal option, which is eternorgestrel. Bleeding sucks. But if they just hang out, if they just give it a minute, it should get better. Now, without doubt, highest episodes within the first three months, boom. Takes a big drop to the second three months. So six months and then becomes amenorrheic. As time goes, that's the norm. But there's been a lot of different medications that have been looked or studied rather to try to reduce breakthrough bleeding on eternorgestrel. Because we know this thing works. If they can just stick with the number one most common reported side effect for discontinuation, which is bloody tissue coming out of the vagina. Now technically it's not tissue. I get that it's kind of disorganized on and off bleeding, but in some patients it can be pretty heavy. Okay, now the typical is it's not that heavy, it's kind of light. Their hemoglobin and hematocrit actually stays pretty stable, but in some it is pretty damn heavy. Okay, so things like doxycycline, because doxy has a mild anti inflammatory effect that's shown a little bit of promise. Of course the idea is that if they are progestin rich, we try to normalize the balance of things by giving them ethinyl estradiol, either alone or conjugated equine estrogen or some kind of estrogen to normalize the pattern. I've done that many times. Or combination birth control pills would do the same thing. Even Ponstol, which is menophenic acid, has shown a little bit of promise. And even short term tamoxifen, although that drug freaks people out, and it should. Tamoxifen has been used in research settings, though not really used clinically. Even Norethindrome, guys. And we covered this. Norethindrone, we covered this in August of 2025. Go back to the archive when an RCT was published out of the gray journal. Now, intuitively, that doesn't make much sense, right? And I think the title of that episode was more Progestin for progestin related bleeding. Because it doesn't make sense, right? You're trying to restore the balance if something is progestin rich. But because noresthindrone does have some systemic conversion to estrogen, there's the catch. It does get some conversion to estrogen. It can basically function almost as a single agent combined birth control pill. Because the norethin drone does convert to estrogen, which helps stabilize or patch the denuded parts of the endometrium which are causing the bleeding. And we're going to get into the mechanism of action here of progesterone related breakthrough bleed in just a minute, guys. We've even covered on this show in the past ulipristal ella. Now remember, typical ella as a emergency birth control agent which can be taken up to five days after unprotected sex. 120 hours. Typical dose of Ella for birth control is 30 milligrams. But at half dose at 15 milligrams for about five days, that has shown promise as well. Just enough to reduce the progestin level where you're still above the area under the curve for contraception. But somehow, if you bring that level down a little bit, it gives the fragile blood vessels in the endometrium that are bleeding and exposed time to recover. My point is, look at all the different things that have been popped published to try to get through breakthrough bleed. Now, some have made sense. Ulipristal, try to lower it a little bit. Estrogen, that makes sense, try to restore the balance. Those make sense. And then there's some that don't intuitively make sense, like the norethin drone. But that did work. And then what about the possibility of transexamic acid? That one has not yet been fully studied. Now it should not work. Let me just. Before we get into the data, because what we're going to cover is a brand new RCT that just came out ahead of print on January 7, 2026. Now, as point of reference, we're doing this in the middle of January 2026. You know, I try to give you stuff that is pretty hot in press. This came out from when we were recording this right now about a week ago. Again, so very fresh in print. Okay, now, I'm sorry, guys. I know I'm sniffing a little bit. I'm still getting over my man cold and I can't believe the world is still spinning if I only have one nostril to breathe out of. But. But I'm working, guys. I'm. I'm feel significantly better. I'm 98% better. Although my voice is still a little weird and I only have one nostril. Nonetheless. What the hell was I talking about? Oh, yeah, right, right, right. Sorry. Thank you. Thank you. The trial. So this was an RCT released ahead of print, so not officially out yet. The title of this is Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users with Transigamic Acid. A Randomized Clinical Trial. All right, just came out ahead of print on January 7, 2026. That is our topic is TXA. One of the options we can add to the list to try to overcome breakthrough bleeding or contraceptive induced menstrual changes with the eternalgestrel implant. I think I've set it up enough. We will be right back. This is Dr. Chapa's obgyn no spin podcast. All right, podcast family. Not being a naysayer or being pessimist, I am a realist, but this should not work. Now, I'm all for, you know, doing research to either prove or disprove a theory, which we're gonna get into here in a minute when I give you the results. I'm gonna do this very quickly, guys. Very quickly. But I'm thankful for the Department of OB GYN out of Oregon Health and Science University out of Portland, Oregon. City of Portland's had a little bit of internal turmoil, but thankfully, at least we're still doing good OB GYN research out of Portland, Oregon. Nonetheless, Department of OB Oregon Health and Science University. This is where this comes from again. This was just published ahead of print about a week ago from when we're recording this, but it shouldn't work. Okay? Again, put it to the test, but it should not work. And here's why. Remember that right now, oral TXA, which is Listida oral TXA, at a dose of 1300 milligrams, taken three times a day for maximum of five days. That's two tablets of 650 milligrams each. Is FDA approved for regular, heavy cyclic bleeding. Regular, heavy cyclic bleeding. In other words, typically ovulatory bleeding, that is in the old term menorrhagia, which we no longer use, but cyclic, regular, and predictable bleeding. Okay? And the reason is, is that that pathophysiology of why heavy bleeding happens with regular, unpredictable periods has a whole different, different pathogenesis than what has happened with a progestin rich breakthrough bleed. Okay? So very quickly, the short of it is when somebody has heavy cyclic bleeding, that's predictable. The reason that that is causing the heavy bleeding is that the shedding of the already prepared endometrial lining, so it's gone through the follicular phase, it's gone through the proliferative phase, secretory phase of the endometrium implantation did not happen. As those walls form, fall, as progesterone now starts to collapse with, you know, the implantation and a corpus luteum not being rescued, then as those shed, as those that tissue sheds, what happens is that there is an increase in fibrinolysis at the level of the basalis layer. And the reason that there's a increase in fibrinolysis is that the body says, hey, no implantation. It didn't work. Boom. Let's clear this. Clear it up, guys. Clear it up. Knock the walls down. Knock it down. We've got to rebuild and try again next month. Now that is the Choppa synopsis of what is happening. The short of it is that the breakdown of the established proliferative and secretory endometrium without implantation has a quick, rapid decline in progesterone levels that causes the shedding to occur, which is associated with increase in fibrinolysis. This is why taking an antifibrinolytic like Listida should work. What? So it makes sense. Okay, that's the pathophysiology of heavy bleeding with regular, predictable ovulatory bleeding is that the body's trying to knock down the walls quickly to retry again. Hey, come on, let's go. This one was ineffective. Let's try it again as it builds up to the next ovulatory cycle. All right, so there is an increase in fibrinolytic activity at the inner layer of the endometrium that's now shedding. And that's why an anti fibrinolytic works. However, with acute or chronic progestin administration, especially with prolonged use or more on the chronic side, what happens is that as that endometrium becomes decidualized and thin, you get an exposed basalis layer of vasculature that becomes very friable, very, very porous. Okay, Very weepy. And what you actually get there is that leaky vessels that are now exposed because they didn't have that endometrium to kind of, you know, soothe them, that no metrial estrogen response. And so what happens is you get this exposed, kind of denuded blood vessels that bleed. In other words, the reason why there's breakthrough bleeding on progestin isn't because there's an increase in fibrinolysis, is because it's vascular exposure, which makes them more leaky and fragile and therefore they bleed. It's the antiproliferative environment of a progestin that has nothing to do with the fibrinolytic process. In other words, the uterus is going, hey, man, our fibrolytic process is fine. Is that our blood vessels are naked and exposed and they bleed. Do you get that? So right off the bat, that's the theory. I haven't even gone into this the study yet, but that's the theory as to why this should not work. So when I saw the title, I'm like, oh, my gosh, does this work? That's amazing if it does. Thinking, of course, that the effect would be there. But in true to form, the theory in this case was proven correct and it did not work. So the tweetable statement, as the authors put as the gray journal includes a tweetable statement, is quote, tranexamic acid did not improve bleeding patterns in contraceptive implant users experiencing unfavorable bleeding. End quote. Always find that funny. Unfavorable. Like, is there a favorable bleeding? Like, has the patient never said, oh, my bleeding is so favorable. It's great. I love it. Are you gonna remove that, Michael? No, I just think it's funny. Same way, like when we tell patients, when patients ask us, guys, have you all done this? I've heard a resident do this months ago. And I was like, hold on, let's just watch our words. And I was just. I was, you know, taking. I was putting in the notes, they were doing the history. I was in the room with our resident, and. And it was on a contraceptive breakthrough bleeding case. And the resident said, oh yeah, breakthrough bleeding, it'll be bleeding on birth control, no problem. That normal. And I said, hold on, hold on a minute. I know what you're saying, and my resident is correct. But if we're saying that that's normal, that means that it always happens. And therefore, if a patient does not have breakthrough bleeding on birth control, is that abnormal? Does that make sense? So be careful what we say. We tell a patient, oh, breakthrough bleeding is normal. Well, is not having breakthrough bleeding abnormal then? No, no, no. So it's not that it's normal. The preferred way of explaining this is, hey, breakthrough bleeding on birth control, especially hormonal, is understandable as an expected and anticipated side effect. It's an expected and anticipated side effect, especially with chronic progestin use. So I don't really like saying, oh, breakthrough bleeding is normal because it's not normal. I mean, the process has been overwritten. It's not its natural physiological process. So no, it's not normal. But it is, however, an expected and an anticipated side effect. Okay, anyway, I have totally digressed. What, what are we doing? Oh yeah. Okay, so why was this study done? Quote, the study was designed to assess transamic acid for contraceptive implant related bleeding, end quote. The other reason it was done is because we need as much help as possible to try to give women some peace so they can continue with a very effective contraception that's FDA approved for three, but clinically used for five years because this works phenomenal across different BMIs. Okay, so short of it is this was randomized, it was double blind, it was placebo controlled, and these were not just new users. Okay, so that's, that's something important because some studies use brand new implant insertion patients. These were just patients who already had it and they just came in saying, hey, I'm having weird bleeding. And they defined irregular bleeding as, quote, two or more independent bleeding episodes or spotting or prolonged bleeding of seven days that are consecutive or more happening within a 30 day interval. So that's the patients who were recruited, they had an internal gestural implant in, they came in for some weird bleeding and they said, hey, maybe they're having this percentage on and off bleeding or seven days of continuous bleed and I need some help. Great. Now if they were enrolled, but they had no further bleeding in the approximate 30 days and they were kicked out, right? Like, well, you never had the symptom, you didn't take the medication, which we're going to kick you out. So it left those that actually had continued bleeding to get transigamic acid in the typical format. Okay. It was oral, 1300 milligrams TID or placebo for five days. Okay. So it's very easy. Hey, not just new users, established users as well. You got weird bleeding, let us know. And if you don't have any bleeding in 30 days, I'm going to kick you out. And then you got randomized either to the TXA group or the placebo. Short of it is, and then they tracked, you know, their bleeding. That was enough to have some kind of protection like a pad, tampon or even a liner. They self recorded that kind of. On an E diary. Okay, I'm not a big fan of E diaries because who knows what they're putting in there, but whatever. And the nice thing about this is that they did give the results as intent to treat. Okay? And we've talked about that in a recent episode. Intent to treat versus per protocol, Intent to treat tends to keep the data more pure. And even though people fall out of one group to the other, it provides the data based on how they initially entered the study, either TXA or placebo. So this is based on the intent to treat analysis, which is the right way to do it. Okay. Short answer is they came back after their assessment and quote, a five day treatment course of TXA did not improve bleeding in contraceptive etonorgestrel implant users experiencing frequent or prolonged bleeding patterns. End quote. Now, one of the things that they state here is maybe if we gave it to it for longer, it would work. But the safety data for five days of TXA as an anti fibrinolytic is well established. People get kind of anxious, as do I given it for more than that, because there's really no data on that safety. So good for them for sticking to the rules. But even as we started and we gave you the theory as to why this does not work, this makes sense. All right, now, now we have proof. Now the theory was one thing, but now this RCT from January 2026 did in fact prove that TXA is probably not the best to go for implant wearing bleeding. All right, so whether you want to do ulipristal for three to five days, if you want to do estrogen by itself, and estrogen and progestin birth control, if you want to give norethindrone at 10 milligrams a day for about five to seven days or so, because this gets peripherally converted, all of those are options. In addition to giving things like ponstolmenophenic acid or any general anti inflammatory medication. We've got options here. But txa, based on its mechanism of action as an anti fibonolytic in this study, it just didn't really seem to do anything. So I am thankful for the folks at OHSU out of Oregon Health and Science University for putting this together. It is very helpful because now it proves what the theory was kind of telling us. The pathophysiology is a little bit different. Anyway, I thought this was interesting. We did cover the progestin Norethindrone being given for breakthrough bleeding back in August of 2025. You can go back to the archive and listen to that. This is a quick little snippet on a new study that just came out on January 7, 2026 for unfavorable bleeding patterns with etratergestrel. And TXA is probably not the medication to give Podcast Family, as always, we're thankful for you. We're glad you're part of our podcast community and now that we've done all that, Michael so let's take it home. This has been Dr. Chapa Zobi Gyn no Spin podcast Podcast Family. Thank you for your support. Thank you for listening. And as always, we'll see you on another episode of the no Spin Podcast. It.
