New IMS Recommendations: Diagnosis of Menopause (STRAW+10)

Ajouté : 2026-05-07

[00:00:02]Good day wherever you are. Um, I'm Professor Steve Goldstein and I'm the past president of the International Menopause Society and currently chair of the council affiliated menopause societies. Um and I want to welcome you all uh to this exciting webinar uh uh new IMS recommendations diagnosis of menopause including stages of reproductive aging workshop plus 10. Uh some housekeeping. The participants are able to ask questions using the Q&A button and the Q&A will be discussed at the end of the presentation. I also realize that the views expressed by speakers are their own uh and may not necessarily represent the views of the International Menopause Society. Next slide.

[00:00:53]Uh this webinar has been supported by an unrestricted educational grant from Besson's healthc care. Uh Beth's Besson's Healthcare had no role in the selection of topics or speakers and has not vetted or reviewed the content of the speakers presentations.

[00:01:12]Next slide. So it gives me great pleasure uh to introduce professor Toby Davilars uh our speaker today. Uh Toby is a consultant gynecologist specializing in gynecologic endocrinology uh menopausal medicine and osteoporosis.

[00:01:33]Uh he graduated from the University of Stellenbos in South Africa. uh earned an MBHB in 1977 and then his masters in medicine uh in obstetrics and gynecology kum laad in 1992.

[00:01:48]He also holds additional qualifications including a fellow of the Royal College of Obstetrics and Gynecology in the UK and a fellow of the college of abstetrics and gynecology in South Africa. He is the director of the Panorama Bone Density Clinic uh and the the Clint Trial Center for Clinical Studies where 36 phase 2 and phase three studies approved by SAPA. Uh for those of you who don't know, that's the South African equivalent of the FDA have been completed.

[00:02:21]He's authored 65 peer-reviewed publications. He's contributed to four textbook chapters and he regular is a presenter at our national and international conferences.

[00:02:33]Uh he's held several leadership roles including a past treasurer and president of the international menopause society as well as president of the national osteoporosis foundation of South Africa.

[00:02:45]and perhaps as important as any of these things, he's a good friend of mine and I'm thrilled to have him here today to present us on this very important topic.

[00:02:55]So with that, Toby, I would say share your screen and then afterwards we'll have some time for discussion.

[00:03:03]Um, thank you very much Steve. Um, so I'm just going to go onto the share screen and that should be it.

[00:03:16]Thank you very much, Steve, for the kind introduction and especially the bit of being a friend of yours. I consider that an honor and uh we've come a long way since uh many years.

[00:03:30]So today I am representing on the chapter in the new recommendations that I was responsible for the diagnosis of menopause including stages of reproductive aging workshop the straw plus 10 and I must also mention that in the final stages of this I was assisted um by Sue Davis also a previous president and um much of the later part of her recommendation ations came directly from Susan.

[00:04:04]Now, why is it important that we need uniform definitions and staging of reproductive aging?

[00:04:13]Well firstly in a clinical context for a clinician to make a meaningful decision um it is important to know at what stage of reproduction the patient is and secondly to manage the patient's expectations in other words can I still fall pregnant should I still being contraception etc but then even more important in the research content we have context text, we have to be able to compare apples with apples when conducting clinical studies. But it's also then important to develop new strategies or to determine the need for new strategies and then we also need it to measure the success of our strategies.

[00:05:04]So up till about 2021 there was great confusion even just regarding the simple diagnosis of menopause and everybody had their own definition.

[00:05:19]So at that stage a group of people wellqualified to do the job decided to stage the special meeting um which they called the stages of reproductive aging workshop and it was held in Park City, Utah in the 23rd 24th of July 2001 with 27 invited participants most of whom had extensive clinical and or research experience.

[00:05:49]in reproductive aging and women. The meeting was sponsored by the ASRM, the National Institute of Aging in the States, the National Institute of Child Health and Development and the North American Menopause Society, these days called the Menopause Society. Um, but the results of this meeting was also then approved by most of the other menopause societies including the International Menopause Society. So the purpose was to address the absence of a relevant staging system for female reproductive aging as well as frustration with the current nomomenclature which deferred whoever you looked at. So the format of the workshop was focused presentations on men menstrual cyclicity andology anatomy etc etc. After each um discussion there was a voting on what happened and there had to be in the end a um majority but in most cases the system was accepted by unanimously. So they needed 70% but mostly had unanimous decision.

[00:07:04]Now it is important even or especially for today's discussion to understand the primary criteria used in the straw 2001 system and they decided in the wisdom that the stages be determined by objective data rather than by subjective s symptoms. So what did they mean by objective data? They meant menstrual cycle length and frequency as the primary markers with FSH values as at that time the best supportive data in terms of what they meant with subjective symptoms. Well, they said that symptoms were deemed inheritant inheritantly subjective or too variable to be formally included in the staging system.

[00:07:58]So what they decided on was a staging system which consisted of seven stages and the first five stages and that was from minus5 till uh minus1 was basically in the premenopause and then two stages in the post-menopause.

[00:08:20]And as they said in their primary um endpoints that they basically um uh based this whole system on the menstrual cycle regularity and they made it very simple at that stage. The early reproductive phase had variable to regular cycles. Then the rest of the reproductive phase was irregular. And then the menopausal transition was introduced when there was a variable cycle length of more than 7 days and different from the normal. And the late menopausal transition when there were two or more cycles skipped or an interval of a minora larger than 60 days.

[00:09:09]The definition of the um menopause was taken as the final menstrual period followed by 12 months of amenora and that is still valid today with the permenopause then stretching over the entire menopausal transition as well as up until the u one year of amenora.

[00:09:35]As you can see um the FSH was just um uh in a simple term said as normal in the here and then raised raised and raised but without any reference to values or what constituted raised.

[00:09:52]What is obviously absent here is the question of symptoms. But you see at the bottom here there's an asterisk and it then says that these stages and that's the late transitional and the early menopausal stages were most likely to be characterized by vasomot symptoms. So the only symptom included here was um that of vasom motor symptoms.

[00:10:23]So that then was the gold standard till 2012 when it was decided to update the uh principle of the first straw system. Now at this stage and I was fortunate to be included in the experts who took part in this and uh you'll also um maybe recognized a few of our other members especially Pauline Mackey as well.

[00:10:56]So the the people representative at this um uh conference were elected from the main um menopause societies around the whole world.

[00:11:19]And presently the conclusions read or reached at this meeting which was called straw plus 10 years is still considered to be the gold standard as endorsed by the IMS for staging reproductive aging as we have not um changed or updated this since the 2016 recommendations which was the last time we published recommendations. ations before the ones that we've published now.

[00:11:53]So what was the aims of the straw plus 10 years and that was um addressing the unfinished agenda of staging reproductive aging. So firstly we aim to re-evaluate the criteria for the onset of rate late reproductive life and early menopausal transition giving given new population-based data relating to FSH the AFC the antimmalarian hormone and inhiban B I think that that was the main point but also to re evaluate the criteria for staging postmenopause given new population based data on changes in FSH and E2 concentrations after the final menstrual period, but also to re-evaluate the applicability of this staging system to women based on variations in body size, lifestyle characteristics and health status and also to identify remaining gaps in scientific knowledge and research priorities.

[00:12:59]So this is what straw plus 10 looks like. Now straw test 10 is still anchored around the final menstrual period and this is defined as the last menstrual period followed by 12 months of amenia in the age group of 45 to 55.

[00:13:22]Um the staging system starts with the monarch and everything else is then in between. Now the first big change that came about was that where we previously just had five substages there now appeared an extra um 3B and a 3A in terms of the late reproduction as well as a 1 A B and C in the early menopause.

[00:13:53]So that was different from the original straw staging but the basis of the staging was still cycle length. Now this changes slightly from the previous straw classification in that we now put in the early menopause variable to regular which this was previously just regular and in 3A the first stage or the last stage of the reproductive period subtle changes in flow or length. Now this is often forgotten that the straw plus 10 actually also refers to subtle changes in the flow or length and mostly what people remember is the menopausal transition which in the early stage has a variable length persistent with a more than or equal to 7-day difference in the length of consecutive cycles. So slightly different wording from the original one. And then we just said an interval of ammonia of more than 60 days in the late uh perry menopause.

[00:15:11]Obviously in the post-menopause um we have a minora. Now the other um change came in the supportative criteria which should always be read in association with the principal menstrual cycle criteria. And here where previously we just uh it was previously just mentioned a raised FSH from the menopausal transition. Well, we now see with the FSH that it's low, it's variable, it's highly variable. And then um the specific um value of greater than 25 international units per liter in the late p menopause and that was on blood drawn on the cycle day length of 2 to5 and it was based on the international pituitary standard and then so we also then have um a raised FSH here and it stabilizes 3 to six years After the AMH was, as you can see, not very specific as well as the inhib, but these are are additions to the original one. The antrol follicle count is also the ultrasonic appearance which is now there and which is actually quite useful I think in uh clinical practice.

[00:16:36]So what about symptoms? Well, previously we just said that it was likely to be in these two phases. It still says vasom motor symptoms likely here or vasom motor symptoms now most likely in the early post-menopausal stage and then increasing symptoms eurogenital atrophy.

[00:16:55]But it's it's it's fairly obvious that these stagings weren't based on any symptoms or that symptoms weren't looked at into any detail.

[00:17:07]So the key features then of the straw plus 10 is that now it was universally applicable and unlike the earliest systems it was designed to be applicable regardless of age, ethnicity or BMI. The clinical utility it helps to differentiate between normal reproductive aging and other medical conditions. But the criteria used was primary still menstrual cycle patterns with the blood test just used as supportive evidence. No mention of symptoms in here, but store plus 10 suggested areas of more research and that being the to develop standardized essays for the other key biomarkers especially AMH whereas this was now done for only FSH and also empirical analysis across multiple cohorts is needed to specify the precise menstrual criteria for the stages minus 3B and minus 3A. So they weren't completely satisfied with that and then studies are needed to characterize the hormonal changes of men post menopause from stages one to two which was also left open. The data from cohort studies of midlife women that were initiated before straw should be reanalyzed incorporating straw plus 10 staging criteria and study data across nations um is necessary especially to provide data on the experience of women from low resource settings. More research data is also needed in women with PCOS in POI unilateraltomy hyerectomy and in women with chronic illness such as HIV infection and those undergoing cancer treatment. So these were suggestions after straw plus 10.

[00:19:06]Now, so IMS has not revised the um recommendations since then, but since that time there has been a few articles which brings into question the validity of the straw plus 10 system. So if you read our new recommendations, you'll find all the uh uh references in that section. But I'm just going to refer briefly to three studies that were instrumental in new thinkings here. And the first one is the Swan study which was the uh study of symptoms across the menopausal transition. A wonderful study. I think it is at this stage already produced over 200 different reports. So there are more than one of the swan studies that has a a a relative bearing on what we're discussing today.

[00:20:10]But there was also a later study, the permenopause meets living observations from the women living better survey and this was um published in 2022.

[00:20:25]Um so in this um uh paper and study the purpose of the analysis was to test a predictive quantitive model relating personal characteristics reproductive ageing stages. That's what we're talking about today. Health behaviors ro stresses satisfaction with life roles to botherome symptoms experienced during the late reproductive stage and the menopausal transition. So this was really a study on behavior in the petty menopause and then we last year had an excellent paper from the Australian group of uh Susan Davis authored by Dr. Islam. And what they did here was a large cross-sectional study of women aged 40 to 69 years. And they studied menopausal staging by the straw plus 10in system of menstrual changes and the severity um as defined by the menopause specific quality of life um medical questionnaire in 5,59 women. So okay you have to understand at this stage that where is the previous studies only basically revised to vasa motor symptoms and slightly to eurogenital atrophy the manquil makes use of 29 items over four domains. So it's a much more um indepth look at the association of the menstrual staging with symptoms.

[00:22:06]So the first bit of the new evidence basically pertains to overlapping of the late reproductive phase and the early permenopausal phase judged by changes in menstrual flow and symptoms. So basically it said that in the women living better survey survey there was less than a 20% 10% difference in the prevalence of a range of symptoms between women in the late reproductive stage and pmenopause or for that matter also the early menopause.

[00:22:42]Now I know it's difficult to always um visualize all the changes. So I'm I'm showing you this all the time so you can see where it fits in. So we're now talking about difference between the late reproductive phase and the early menopausal transition. Whereas it is basically given in the as in the late phase here as either regular or subtle changes in flow or length with here a much more defined um uh difference in the length of consecutive cycles. The point is just that the symptomatic profile of these phases overlap and even differ very little from the early menopause.

[00:23:37]The second one that the Amy study demonstrated that women even with regular cycles but change flow. So that means heavier or lighter with or without vasom symptoms which was classified as premenopausal by straw plus 10 had an indistinguishable symptom profile as captured by the manquil um system and and from that was from early women also for early menopausal women with or without vasom symptoms. Both groups with vasom motor symptoms had equally more severe symptom profiles than both the groups with no vasom symptoms.

[00:24:23]Okay. So what is being shown here now is that in order to be in the late menopausal transition cycles can still be regular with or without hot flashes and that the symptom complex as measured by a very um sensitive mechanism sassage manquil um there was not much of a difference between these groups.

[00:24:57]And then the last um conclusion was that the findings aligned with previous suggestions that the menopause transition commences before the cycle length varies by 7 days and support the conclusion that women with change menstrual flow and vasom symptoms are likely to have entered the menopause transition.

[00:25:22]So what then about the permenopause? So the previous section was about late reproduction versus perime early per menopause. But now we're just going to have a look at symptoms in the pmenopause.

[00:25:36]So just to go back again to straw plus 10. So in the early menopausal transition there is a silence on any symptoms and um it is in the late permenopause it said that it would be likely and most likely in the early menopause. So does that hold up to present standards? Well, in both the Swan and the Amy study, it was shown that the majority of menopausal symptoms emerge in the early permenopause with the onset of VMS often in the late reproductive years.

[00:26:15]So, not quite what we believed. And then Swan and the Amy study have demonstrated the greatest reporting of EMS in the pmenopause. So actually um more though than in the early postmenopause also in other symptoms this comes from Swan study vaginal dryness doubles in prevalence from pre-menopause by the late pmenopause.

[00:26:41]So it doesn't really sit right on the right there as in the presence the present system and memory complaints and brain fog occur during the permenopause with apparent resolution in most women after the final menstrual period also partly from the swan studies but the exact um references you will find in our paper.

[00:27:05]So what now becomes important is the timing of menopausal symptoms. And these findings indicate that the onset and peak of severely bothersome menopausal symptoms occur earlier than described by straw plus 10 and often in the context of relative estrogen sufficiency.

[00:27:26]So in other words, there doesn't need to be an absence of periods for symptoms to appear. And similarly, several physiological changes attributed to severe estrogen depletion emerge earlier in the menopausal transition, but they do not significantly worse when estrogen insufficiency becomes more severe and is abstained um after the last menstrual period.

[00:27:54]What also becomes important is the correlation between menopausal symptoms and hormonal changes. So the impact of menopause has mostly been derived from studies comparing the postmenopausal with premenopausal women and from interventional studies in the post menopausal women and this has led to the broad conclusion that the overriding impact of menopause is a triple to estrogen loss.

[00:28:24]But the longitudinal swan study has shown that estradiol level blood levels are actually higher and that's average levels because you have fluctuating levels are higher in the 5.5 years preceding the menopause than in the prior than in prior years in 45% of women.

[00:28:46]And also sexual desire and arousal dysfunction doubles in prevalence in the early permenopause compared with premenopause despite no evidence of a change in testosterone blood levels during the natural menopause transition.

[00:29:01]So what this then basically means that we can ask the question are hormonal changes the sole or the main driver of menopausal symptoms.

[00:29:12]This prompts caution in attri attributing the symptoms and health effects of menopausal transition totally to estrogen insufficiency and the need for greater understanding of the changes occuring in the late reproductive years and early and late pmenopause and that obviously also cautions to just um hormonal management of these. So what then are the key recommendations and messages that we've given in our chapter?

[00:29:44]Well, we feel that for the present moment staging of reproductive aging should still generally follow the straw plus 10 guidelines.

[00:29:55]We should re realize that the diagnosis of menopause is a clinical diagnosis not dependent on special investigations.

[00:30:04]Supportative criteria should actually should though be used for staging women who cannot be staged based on menstrual cycle characteristics such as somebody who had a hyerectomy.

[00:30:16]But presently the gold standard straw 10 criteria for determining menopausal stages are based on menstrual cycle characteristics including regularity skipping of menstrual cycles with blatist um conducted only as supportive criteria.

[00:30:34]So we then say that while the straw plus 10 guidelines we which rely on the menstrual psyche regularity provides a useful clinical framework for identifying stages the onset of menopausal symptoms is frequently earlier than suggested and together with changed menstrual flow may signal the onset of the menopausal transition in women. Then just the obvious in women um younger than 40 years of age, the onset of moderately to severely bothersome vasom symptoms regardless of menstrual cycle changes should prompt a clinical evaluation of reproductive staging and the diagnosis of PUI should be suspected in women younger than the age of 40 with aminaria or irregular menstrual cycles for more than four months and with confirmed FSH values larger than 25 international units per liter. And then lastly just the menopause between the ages of 40 and 45 years is termed early menopause.

[00:31:38]So what then are the next steps and this is my personal opinion. I think that we should maintain the status of draw plus 10 as the gold standard for staging based on cycle length and frequency for research purposes but make clinicians aware that symptomatology may not correlate with the straw staging.

[00:32:01]So we should encourage more research comparing straw with cycle flow and other symptoms like in Amy and also encourage research into the treatment of symptoms in the pre-menopause because this is really clinically the big question is how do we treat these patients which we now know can present early when we don't really have a proven um estrogen u shortage.

[00:32:31]So what it then basically amounts to is that for research purposes it's probably still better to always report on this but the present the staging of symptoms and where they appear and what they are are completely inadequate and this should be revised and maybe the international menopause society can be uh initiate a straw plus 25 or 26 or 27.

[00:33:07]Thank you for your attention.

[00:33:15]Thank you very much uh Toby and I guess you can stop sharing your screen. Um it's always interesting uh when a presentation raises more questions than it answers.

[00:33:29]Um, we people should be aware that if they want they can put questions uh in the Q&A. I've got a bunch of questions.

[00:33:37]So, you and I can have a little bit of a discussion while we're collecting some of these questions. Um, first of all, I don't know about in your country, but if you follow social media at all in in the states, I think the term per menopause is becoming amazingly problematic from a treatment point of view. Now you didn't really get into the potential treatments for some of these different stages um but the number of women I think who are told that they are permenopausal uh who are in that early stage uh that may have the 45% of women that have elevated estradiols uh very erratic production of estradiol as opposed because they're olo and anovulatory uh loop cycles or they don't don't develop a dominant follicle, which is one of the reasons that Nette Santoro showed originally that estradiol levels can go up before they go down. Without a dominant follicle, you make a lot of estradiol.

[00:34:39]Um that those women are very very different than a woman who's got three months of amenorhea who if you followed her for the next nine months, she'd now fit the definition of menopause. But you never know that the bleed she just got is the last one she's ever going to get. So this 12 months of no bleed to me is very very problematic. Many of these women in the late permenopause are going to have very low if not absent levels of estradiol.

[00:35:08]But so the concept of and I hate using the old terminology but it's all over the internet. HRT the R in HRT is replacement.

[00:35:18]So if somebody clearly has low estradiol and is having vasom motor symptoms, we use menopausal hormone therapy. But if somebody is having very erratic pulsatile even elevated levels of estradiol giving them traditional uh doses of you know estrogen plus progesterrogen uh doesn't suppress endogenous ovarian function and so is really the key for many of us in the earlier permenopause if there's no contraindication is to suppress ovarian function and that's done conveniently with lowd dose birth control pills. patches, rings, um, to turn off ovarian function and substitute a very stable amount of estrogen and progesterone all month long. But they're both considered permenopausal.

[00:36:09]And so to a lot of the new clinicians, you realize the membership in the North American Menopause Society when I was president for years hovered at 2,000.

[00:36:19]Last year it surpassed 12,000 people.

[00:36:21]There are a lot of newcomers who want to be menopause and permenopausal practitioners and often their knowledge of the the what you just presented is rudimentary uh and I think the number of you know 45 year olds having irregular cycles uh maybe the 45% with elevated estradiols who are given an estrogen patch which is why there's a shortage in the United States of estrogen patches and prometrium uh is is huge that everybody's being treated that way. So I wonder if you would comment. I I just think that this early and late pmenopause are two often very different hormonal uh situations and we'll talk about the symptoms in a second, but very different hormonally. Yet, because they all come under this umbrella of perry menopause, they're often treated the same by a lot of clinicians who are well-meaning but not necessarily very uh understand the the fine-tuning.

[00:37:23]Yeah, Steve, I I cannot agree more that to the clinician this is one big headache and it is being um made worse by social media because somehow the social media has gotten onto this bandwagon and they it's encouraging um people with virtually any symptom to be classified as per menopausal and that doesn't help us a lot um because we just have not got the tools to manage those patients with and I think we have to be very careful. Um, if I I agree that if you want to do something, it would probably be to stabilize the large fluctuations of hormonal changes that you get in the natural pmenopause and that would be by suppressing the ovarian function and that means the oral contraceptive pill. But there is and and and you do get a certain degree of success on that. um and it at least will also um give regular cycles if irregular cycles are are the in but that's not a panacea for these patients there's something else as I said it's um patients who are even in a higher estrogenic environment than um other non-symptomatic patients who are symptomatic patients and we simply don't know why um But to use those symptoms now in order to change our classification, I see a problem. Um, if we have a look at the original criteria that was used by the wise men and ladies in 2001, they said that the symptoms are inherently um biased and difficult to follow. So I think that if one wants to use symptoms, you're going to have to use a system like menol and you're going to have to look at all 29 criteria over four domains before you start making any sense of it. The days of just going on phasot symptoms, yes or no, HRT or or the um pill um yes or no, I think that's gone. But and that is where we as the sort of more traditional practitioners fall quite short from some of the so-called functional doctors who will concentrate on other aspects of the patient's life and um tackle issues which we don't even think of and then they will claim success from that but that's not really success it is just a different angle to the problem. So this is a great discussion and I mean there's a couple of questions here and I'm going to summarize and and see if we can't continue this discussion. Um you know you presented quite nicely that there are people with regular cycles who have some of the same symptoms as the people with very very weird psy you know unusual cycles. Uh, and one of the authors of where Perry menopause meets life, Marcy Richardson's on this call.

[00:40:39]Uh, and she's saying, "I wonder why you insist on sticking with straw when you've so clearly explicated uh, its limitations."

[00:40:47]Uh, and I guess my point is you're right. I mean, that that article that about where permenopause meets life, you know, patients are coming in all the time now with all kinds of symptomatology assuming that they're permenopausal.

[00:41:02]I have to tell you, I'm giving up trying to predict what I often tell patients, and I don't know if you would agree with this. I don't have a clue how much of how you feel might be quote hormonal, but I think I can find out because if you're having irregular amounts of production of estradiol, often with little or no progesterone, if you're olo or an ovulatory, once again, if there's no contraindication, I use continuous lowdosese birth control pills. ring or patch to turn off their menstruals fl their ovarian function substitute this stable amount of estrogen and progesterone you know for the next eight weeks and I say you will tell me because if this this and this symptoms get 80% better then I think they were hormonally mediated if it didn't touch that symptom and that symptom then I think that's got a different ideology in other words it's very difficult sometimes to extract How much of these things that you're seeing on men call might be life stressors, the sandwich generation living in in a world that's going to hell in a hand basket as we would say and how much of this is hormonal. Uh and uh you know so I'd be curious to see your thoughts and what that goes along with one of the other questions here with with the lack of difference in symptoms between different menopausal station symptoms stages.

[00:42:29]Could it be that the men call is asking about symptoms which are not related to menopause or I think what she means is not related to hormonal changes.

[00:42:39]Yeah. I mean obviously that that is the case but to the patient that doesn't matter. The patient has a problem and it falls into the period of time which we call the perry menopause. So it becomes our problem. Um just to answer the uh question of the um author of the the previous paper um who said why why do I still hang on to straw if it has clearly outliven it strength? I I don't think it's out living its thing because if you can give me a classification which um on symptoms alone makes sense then I would gladly listen to it. But if you have a look at what was said in Swan in Amy and in your paper, there's no U uniformity in terms of where we can get up to a classification system. So the I think the better question though is whether we need a system at all.

[00:43:42]Um and so if we do think we need a system, then the only consistency that we can do is to go by the menstrual cycle length. We've got plenty of papers showing how it performs under certain circumstances, but to have but to to admit like I've done in this that in terms of symptoms, it doesn't help us at all. So I think at the Nancy the the the bigger question is whether we actually need a system.

[00:44:12]>> Here's a question. Is it still recommended to corroborate the FSH a second time in both POI and women who have had a hyctomy?

[00:44:21]>> Um it it it differs. I think in our latest Nick Penn in his latest one um said just one is enough. I'm not quite sure about that now. Um but I personally would um look at the um clinical circumstances. Sometimes it's quite obvious what you deal and one very raised value would be sufficient. If you have a intermediately raised value, it's probably best to repeat it in 6 weeks which basically puts you then in a different cycle if there is still cyclicity present.

[00:44:56]You know, I think I assume this questioner when they said hyerectomy means with intact ovaries. Obviously that ovaries that's easy. Sure.

[00:45:04]>> I would be very careful. Um, you know, that FSH is a snapshot of ovarian function on that day and the variability is tremendous. Um, so I, you know, it's not a matter of whether you get a second or not. Just understand the limitations of a single FSH. the number of people when I transition somebody from birth control, you know, hormonal birth control, um, to see if they've drifted into menopause, I tell people that it works 100% in one direction and 70% in the other. And what I mean is we usually take them off of this for some period of time, which is variable depending on I I use two weeks, and then I'll measure FSH and estradi. And I tell them that obviously if estradi is up and FSH is down, they are not menopausal. and maybe we'll go back on that hormonal contraceptive for 6 or 12 more months.

[00:45:56]But if they have an FSH that's elevated in estradiol that's low, I never tell these women that they're menopausal. I tell them, "Your blood work was in a menopausal range." And in fact, I give them a slip in case three, four months from now they have a spontaneous bleed, I say, "Go get blood work first, then call me." Because if I can document that they bled because they had a blast of some ovarian function, then they're not labeled as being a post-menopausal bleeder and don't have to undergo a you know million-doll workup for post-menopausal bleeding. You understand they bled because they had some reversal. And the number of women that I have seen who had menopausal numbers of FSH and estradiol and two three months later at age 51 or 51 and a half having coming off you know hormonal contraception totally reverse those numbers and now have an elevated estradile and a low FSH. So understand that those kinds of uh lab tests are simply a snapshot of function that day.

[00:46:58]This question is >> I I I think that we should also see everything in clinical context. Okay. If you um so let me just see. Sorry. So Steve, can you still hear me?

[00:47:11]>> Yes, I'm hearing you.

[00:47:12]>> Okay. Um sorry, I've just had an interference here, but let me let me just uh get out of my slideshow there.

[00:47:21]Um okay, you you can still hear me. Um uh Steve, I think we should see anything in clinical context. Um if you have a 49year-old with a previous hyerectomy now presenting with severe hot flashes and an FSH of 80, I would not repeat that. I think it's obvious. But if it was a patient much younger with sort of no real symptoms, then I would and I had a value of about 40 45, I would repeat it again in a different cycle.

[00:47:54]Okay. Um, pmenopause, can we state that it could start before 40 in some women that are symptomatic or is it absolutely after 40 years of age? That's easy.

[00:48:05]>> U, sorry. Um, Steve, you you answer that. I'm just trying to get back.

[00:48:10]>> So, yeah. In other words, I have to tell you when I give a talk like this, you know that that straw uh chart flowchart that you have, I show that and then the next slide I have it with big red circles around the words variable. One of my problems with straw is that that may work for a population but the amount of variability that I see and so sure we sometimes say that the average per menopause is four years average could be 10 and that the average menopause at least in the states is 51.4 but clearly there are many women who can start to do this prior to age 40. So the age itself is really uh not not the issue. Uh, next question. Would a contraceptive pill in early parameters reduce symptoms as brain fog, low mood, or would you still add lowd dose HRT?

[00:49:01]You know, I don't know about you, Toby, but you know, first of all, I like I said, the R in HRT is replacement. I'm not replacing unless I feel that there's absent estradiol. Um, if somebody comes in and they have brain fog and low moods and I put them on this uh contraceptive pill for eight weeks continuously and their low mood doesn't improve at all, then perhaps there's a different ideology. It is clearly not her hormonal swings, which is what I think people in early permenopause have. And that's maybe >> Okay, Steve, I I I'm I'm back on the platform and I just got kicked off, but I'm back on it now. Um so um certainly if the the auto contraceptive pool that you'd use in the later phases would be one of the new generation pills with um low doses of natural estrogen. But if the patient does not respond on that, it's not going to help adding anything to that. So I basically agree with Steve. No, I would not add estrogen.

[00:50:07]>> Right.

[00:50:09]Tara Weir, thank you for your great comments, Dr. Coulson. basically treat early pmenopause and late reproductive stage suppress and adbeback in a similar way and late permenopause more like the menopausal with MHT. I agree. Based on this approach, do you think the use of slind for those who don't have that?

[00:50:27]That's a joperinone progesterone only birth control pill plus or minus transdermal estrogen might offer more symptomatic relief than marina plus transermal estrogen and those who have contraindications to combined hormonal contraception.

[00:50:43]Yeah. I mean the you know I think really what that says to me and I ask you Toby you know not everybody is a candidate for our hormonal contraceptives and so if they're not what do you do?

[00:50:56]And I think that the concept of slind, you know, a progesterine only pill, especially with joinone has can work pretty well. Um, and I think that uh six one half dozen another. A lot of people seem to prefer uh the merina, but the nice thing about slind is it gives it will suppress ovulation whereas uh merina if there were spontaneous ovulation doesn't prevents pregnancy. So I think I think you have to kind of like be willing to come up with some creative alternative in people who have contraindications.

[00:51:33]>> I I think Steve, you know, this just brings us back to the point that there's no proven best um option in these patients that are not yet completely post-menopausal and uh so various things can be tried as long as you just do not do any arm. So look at the contra indications and that would certainly be a approach to go marina with transdermal. It is different though when the patient is clearly post menopausal and the symptoms are clearly related to estrogen then we just follow the normal guidelines.

[00:52:11]>> Uh here's a a question says I have found that ethanol estradiol and birth control pills does not help with the symptoms like irritability, hot flashes and sleep. When I switched to estradiol, their symptoms in early pmenopause symptoms get better. Have you seen this?

[00:52:27]This is maybe why more people are using estradiol maybe paired with IUD or joinone only pill for cycle control. Um no I have not seen that. Um that's not been my experience in general at all. Uh I in fact I have so many people who have feel so good on lowd dose birth control pills with ethanol estradiol that when they get to be 51 52 and I suggest maybe we should come off and do some blood work to see if you have any more ovarian function because why would I give you something to suppress ovarian function if you no longer have any? I call them my pill junkies. Some of them feel so good that they don't want to rock the boat. And in fact, you know, Nette Santor and I wrote the very first textbook of permenopausal gynecology 24 years ago. And the person who wrote the chapter in that book on birth control pills was Paty Sulac, who really is the person who gets credit for going to 244 instead of 217 in the lower doses. She used to recommend keeping people on pills until they were 55 because by then 95% of women were menopausal. I've never bought into that. I like to individualize because I think that uh if you did that, you're going to be treating some women for one, two, three years of what would have been menopause with lowd dose birth control pills, which I'm using to suppress erratic ovarian function. If there's no more ovarian function, why would I give them birth control pills? So, I like to individualize based on how they're doing, how they feel, are there any coorbidities, is, you know, what's going on on a case-byase basis.

[00:54:03]This next question, thank you for a great presentation. It's very valuable to rethink straw plus 10 framework in real clinical practice. Early parmenopause may help identify previously undiagnosed endometriosis as estrogen fluctuations can exacerbate symptoms and make the condition more apparent. Suppressing ovarian function uh to achieve hormonal stability may therefore be a reasonable approach in this group. Okay. However, pmenopause is heterogeneous. Couldn't agree more. How would you approach women without endometriosis for example those with PMS, obesity or PCOS where management strategies may differ Toby? What do you think?

[00:54:43]>> Yeah. So the question is about because and >> yeah I mean I think the question is more one of you know it's pretty simple. I mean it's really saying the heterogeneity of pmenopause. You have some people you know that are just not very very healthy going through erratic ovarian function. you've got some people with bad PMS or people who marked marketkedly obese or people who have peacos as you call it you know so don't you need to modify your management strategies depending on what the clinical backdrop is I think is what that question is asking and the answer is obviously yes the the harder answer is what do you do for some of those unique difficult situations um you I mean do you modify your treatment for people who are marketkedly obese? Do you modify your treatment?

[00:55:37]>> I certainly I certainly would and somebody who is is obese probably first needs treatment for the obesity um looking at the cause of that pro possibly using modern drugs etc and then to see what happens to the symptomatology. the group of patients with PEOS does not fall into the straw classification.

[00:56:01]Um that that still is one of the areas which needs to be looked in more carefully. Um and patients with severe um premenstrual tension for instance is again a completely different subgroup and should be addressed according to the principles that we have uh for PMT.

[00:56:23]So one should always try to um if you're dealing with a patient with complex symptoms to look at the most bothered symptom and to see whether that in itself can be treated and then see what happens to the other symptoms because otherwise you're going to get you're going to get nowhere. You sit with the patient in front of you and the the words just keep on coming in the complaints just keep on coming in. So you got to take it from one side. You got to deal with the most bothersome symptom. That is an acceptable principle in clinical research as well. And then concentrate on on the most bothersome symptom and then do it stepwise downwards from there.

[00:57:12]>> Do you recommend cyclic progesterone monotherapy 12 to 14 days in the treatment of pmenopause?

[00:57:20]Well, I I I wouldn't say that it is a routine way of managing the perimemenopause, but obviously if we're dealing with um endometrial uh problems resulting from that, it is excellent therapy to control both the cycles and to um also protect the inometrium. So just um remember that many of the signs of per menopause so that's the cycle variabilities are caused by deficiencies in progesterone and so it could be addressed in that way and probably what works best under those circumstances is what they just um described the marina intrauterine system >> I think that will help with any bleeding abnormality I'm not sure that that has any effect on erratic estradiol production ction in people who are ulogatory.

[00:58:14]You know, I ask you, you use the term estrogen shortage, you know, in other words, that that not everything is related to that. Do you think it may be, excuse me, the delta estradiol rather than the absence of estradiol?

[00:58:30]In other words, if people are making erratic amounts, you know, and you measure it, it's not in a menopausal range, but there may have been a dramatic drop. So >> so we we already know for many years from um premenstrual migraines for instance that the migraine is um triggered by a drop or a variation a fluctuation in the estrogen level. So I think we we have plenty of of evidence for that. So that the variability in levels of estrogen certainly um will explain a certain amount of the symptoms that we have in the permenopause. But you'll agree with me that even if you um do completely eradicate that by giving something that suppresses ovelation. So now there's no variability sometimes it does not have a positive effect on the um symptomatic control. So there's not always a correlation between that but certainly in certain instances it is the variation that is the problem and not the absolute value whether it being high or low.

[00:59:42]Um this questioner wants to know also I want to learn your opinion about vaginal which is so popular or rectal newly popular micronized progesterone.

[00:59:53]Okay. So um the uh the progesterone can really be given in any way in which it will reach the bloodstream and it will influence the endometrium because that's basically um the main role of giving the progesterone. Now we know that if you do give oral um micronized progesterone it can induce um insomnia or or somnulence and uh but if you do give it in such a way that it does not um go through the liver then we do not see those effects.

[01:00:33]So how can we give it without going through the liver? We do not actually know of any way in which to give pure progesterone P4 through the skin.

[01:00:43]Although the compounding guys would would have a different opinion on that but um I have never seen it to be effective. So you can either give it vaginally or rectally under those circumstances. It is um absorbed adequately. The question is just whether the patient would be happy with doing that on a daily basis but it does um avoid some of the side effects. It's not in all countries that it is registered to be given that way but um for every method of giving it either rectily or vaginally there's one country that does allow it. So you can really decide yourself. Um I hardly ever use the progesterone as Steve just now said for symptomatic control. It is mostly for the sake of the um endometrium. So if you want to use pure progesterone, yes certainly you can do that. If you don't mind force um the non-natural progesterine uh you can go with the marina intrautron contraceptive device or a oral tablet called um dydrogesterone. I think you do have it in the states as well called dufeston in most parts of the world and that is pretty much like um the natural progesterone and it is um absorbed from the gastrointestinal system without those side effects.

[01:02:15]>> Here's a question about back from Marcy Richardson. Steve and Dr. Toby, what about a woman who doesn't tolerate OCPS?

[01:02:24]There are a fair amount of those. Um I I know my opinion often uh I will try transdermal or a vaginal ring for hormonal contraception and sometimes people who did not do well with pills do much better with a nonoral formulation if they cannot tolerate any of those uh then yes I do have some people in whom I use the joperone only birth control pill uh and possibly might add back some estrogen Um if >> yeah agree with that >> this is more gerine with your talk I guess this says if we stick with straw criteria for research we will exclude a large group of women who have yet to have cycle changes but maybe in the early late stage menopause transition.

[01:03:12]This is problematic because findings may not be generalizable to women without cycle changes. How do we justify continuing with using straw? Would it be better to use an age range rather than cycle changes?

[01:03:26]>> Should I just repeat the last sentence?

[01:03:29]>> It says, "How do you justify continuing with using straw? Would it be better to use an age range rather than cycle changes?"

[01:03:36]>> Okay. Now, age range doesn't help at all. Okay. Um, so the the the reason why I say that we should retain the system is that you can do like was done by Sue and them as Sue Davis and her group in the Amy study. They did the straw classification but they also then had a look at the menstrual cycles irrespective of the straw system and that's the and and then correlated that with the menol system. So that's the only way in which we can really be able to see if that is repeated over many different populations. Then we can see if there is a definite pattern which we can use to replace straw. But at the present moment we there's just no um classification using symptomatology that's going to give a consistent and usable form for research. So do your own bit but always compared to the store system and compared to just vasom motor symptoms or compared to a compounded model such as menacol.

[01:04:49]>> So Dr. Harlo who's first author on your straw paper uh says and this is great heavy menstrual bleeding is associated with fatigue and increased risk of iron deficiency regardless of stage. I could not agree more. Given the noted increase in amount and duration of menstrual bleeding in the menopausal transition, it is not surprising that some symptoms are similar across reproductive life but increase in frequency in the menopausal transition. How might we best incorporate the increased bleeding and flow in the straw 10 system?

[01:05:22]>> So is that Shan Har?

[01:05:24]>> Yeah. Hi.

[01:05:27]She she was the main driver of straw 10.

[01:05:30]I would say the mother of straw plus thin. Yeah. Um that um I I I certainly agree with you that um well if being fair on what we decided there it does say that there are a subtle changes in flow can occur towards the um uh last phases of the permenopause.

[01:05:52]But that is the only mention that we really make of flow. And I agree with you and I think certainly um Sue Davis would insist on it that flow is as important as is the cycle length now especially if flow um is um linked to some other problem but yeah I agree.

[01:06:16]I I I mean one of the take-go messages maybe not even for straw is that we should be checking iron feradin t-at iron binding uh in women it's not enough to just say you're not anemic because low iron stores certainly cause fatigue restless leg a lot of symptomatology is related to iron and I think it should become a routine part you know a lot of at least obgyn will get a CBC and a thematic It's okay. They say, "Well, you're not anemic." But measuring iron, I think, is crucial. So, thank you for that comment. Um, >> Steve, can I ask Shan a question?

[01:06:56]>> Sure. I'm not sure.

[01:06:59]>> Oh, she can't answer that.

[01:07:00]>> She'd have to type her answer, >> but she can type it. And just very shortly if she agrees with me that we should still stick to the um straw plus 10 system as the skeleton as the basis of our staging and then correlate symptoms with that or or what what would would her opinion be on the future of straw blast?

[01:07:23]>> We'll see if she types it in because she also wrote great talk and discussion at 10:02. So I wonder if she's even still on.

[01:07:30]>> Okay. Uh I don't know if we're supposed to end when but uh this is a lot of fun. So uh for the iron discussion I think treating to optimal feradin's crucial too not just normal and symptomatic women.

[01:07:47]That's a good point. I would agree with that. Will you please comment on checking blood FSH neester dial during the permenopausal period for determining which therapy to give for menstrual cycle irregularity/VMS?

[01:08:00]Does the spirinone only pill have protection for the endometrium when estrogen is added for VMS? When do you recommend endometrial biopsy during the permenopausal cycle irregularities?

[01:08:12]>> Well, Steve, if you take that one, >> yeah, I can say first of all, I don't ever recommend endometrial biopsy because a blind biopsy is not a biopsy.

[01:08:22]I hope everybody understands a biopsy is either needle biopsy, incisional biopsy or excisional biopsy. What you are doing is endometrial sampling. And sampling if you look it up is when you take a piece of something or like an aloquat and you believe it represents the entire thing.

[01:08:39]For instance, you go to a reservoir, you take some water out as a sample, you think it is indicative of the entire reservoir. When we do indometrial sampling, it's been well shown that if the process occupies less than 50% of the surface area, it can be fraught with error. And ACOG recognized that in 2012.

[01:08:57]So I am not a fan of endometrial biopsy.

[01:09:00]You get away with it most of the time because most of the time there's not pathology. Uh drosperone added only pill yes should give you endometrial protection. It's a little more drosperone than what you have in most birth control pills. So that's enough progesterine for endometrial protection.

[01:09:17]Uh checking blood FSH and estradiol during the parmenopausal period for determining which therapy. I I mean you could, but I don't think you necessarily have to. I I I think that the the menstrual I get so much information from taking a good menstrual history in these permenopausal women. And now with these trackers that more and more people have, the interval between cycles tells me if they are ovulatory, if they're oloy and anovulatory. Uh and you know if if they've been if they're getting bleeds on any kind of you know what happens is for some people in pmenopause who are still in the early phases, they will increase cycle length, not necessarily greater than 60 days, but they may increase some of their cycle lengths.

[01:10:05]It's when they decrease their cycle length that we all have to do an endometrial evaluation. I tease and tell somebody who's bleeding every 40 days consistently or for you know that no one ever got a DNC hyctomy or an evaluation for bleeding less often. But when they bleed 19 days, 18 17 days apart then I'm obligated to prove they don't have hyperplasia or a polip or something else. Although 79% of those people have dysfunctional and aviatory bleeding. So I think the the cycle is as or more important. I think if it's really spacing out and they have VMS, you know, then you could measure those things, but in general, I think uh you're going to go with symptoms. Would you agree, Toby?

[01:10:52]>> Yeah, I I have no comment on that. I can just see that I've now got gotten back to um Shan has actually um answered now and she says yes I agree we should keep straw plus 10 and incorporate the new data available on symptoms and discuss how to improve an algorithm that incorporates clinical decision making.

[01:11:14]So I'm very glad to see that that she basically agrees with what what I said.

[01:11:21]>> Okay. Uh so I think we're drawing close to the our time limit. I appreciate how much people have stayed on. I would ask Marian if she would uh there's a few more slides. Please don't leave just yet that the IMS wants to have you see.

[01:11:38]That's important.

[01:11:41]So Marian, if you will share your screen and put up the slides.

[01:11:47]I could do finger puppets while we're waiting.

[01:11:53]Um, Marian, oh, we got a thank you from Marcy Richardson. It's nice to see some of the people we know who are giants in the field have signed on. Um, well, if I don't get the slides from Marian, I will tell you that there's any number of things. Oh, here we go. Great.

[01:12:18]So the the International Menopause Society has a tremendous number of things. There's a QR code that I would love for you to shine on. Uh the World Congress will be in Rio uh the very end of September, beginning of October. It's going to be a great meeting chaired by Professor Antonio Cano of Spain. The council of affiliated menopause societies which I chair has 69 or 70 I think we just in incorporated somebody else uh societies from all over the globe. Menopause Info is uh our consumer arm. Climactic is the journal official journal the international menopause society. There's a tremendous amount of online education. If you go into uh IM Society, and there's only one S, it's IMocciety, not imsocciety.org.

[01:13:13]Uh World Menopause Day is October 18th.

[01:13:16]And I would tell you that if there is a free one-year limited professional membership for anybody uh who is from any of these c countries that have a affiliated menopause society. So, I wholeheartedly um suggest that you go on to the IMS website, that's imsocciety.org, uh and sign up for free limited uh professional membership for a year. It's crazy not to go ahead and sign that. I think it's pretty clear. Next slide.

[01:13:52]And then I've already mentioned uh we hope to see you all in Rio uh for the 20th World Congress on Menopause September 30th to October 3rd. Uh it's going to be a great program. I'll be there. Toby will be there. We'll look forward to meeting many if not all of you in person. Uh and with that, I want to thank uh Toby for an amazing uh talk.

[01:14:16]uh and as I said it it sometimes raises more questions which is is a sign of a good talk and also want to thank BT and Marian for their uh support uh logistically.

[01:14:30]So whatever time it is in your place uh until next time until we meet again thank you very much.

[01:14:38]Bye bye.