Selecting an effective, safe, and convenient contraceptive regimen

Kurt Barnhart, MD

So it’s really a distinct pleasure to kick off contraception day at ASRM, which was also developed in cooperation with ARHP. It’s a young, but I think, outstanding tradition here at ASRM to reflect that contraception really is an integral part of what we do ourselves as well as for our patients.

It really is wonderful to put this program into one kind of focused area as it allows us to get our fill and still enjoy the meeting. With that aside, the real pleasure is to introduce Anita Nelson who is going to talk to us today. Anita has a distinguished career as a Professor at the David Geffen School of Medicine at UCLA. She really is a model clinician and researcher. I asked one of my colleagues about her yesterday and they said Anita really is the model in terms of someone who cares, produced, wants to make change, and is one of the few people who can actually say she’s done it. So with that aspect we get to enjoy Anita’s well thought out talk. Thank you very much and welcome.

Anita Nelson, MD

We are going to be covering a somewhat ambitious overview of contraception right now. I want to talk about the short- and long-term risks and benefits. We want to certainly talk about convenience, cost, and availability of a whole range of hormonal contraceptive methods. We want very much to be promoting practices that can encourage successful utilization of contraception. And we want to talk a lot about the barriers that women face trying to use contraception. Now a lot of this is US-centric and I apologize but maybe we can share from the international perspective some of the other barriers that you may have available.

There will be discussion of off-label and non-approved uses of products and devices as continuing education. And I will always cite where those references came from.

Kurt had a couple of, you could see he was dripping with conflicts of interest as he introduced me but I do have substantial conflicts of interest. My only hope is that one of them will weigh out the other and that if there’s anybody out there that I’m not working with please let me know. I do want to complete the list.

So we are focusing today mostly on the barriers and trying from an overview standpoint seeing what it is about contraception that makes it as frustrating and intriguing as it is and why we have not yet achieved all of the success that we had thought we would with the introduction of the pill in 1960.

This is a snapshot from last year—worldwide 210 million pregnancies each year. And of those, at least 28% are unintended, 22% end in abortion. So that is a clarion call that we can do a lot more with family planning. More than 200 million women in developing countries; what are they able to use? Well 64 million rely on traditional and traditionally less effective methods of contraception and 137 million use no method at all. Coming back to the United States—driving it home—the estimates have been that half of the annual population growth in this country is attributable to unintended pregnancy. So clearly we’re guarding our borders but we need to do more about that sperm, you know if we’re going to be helping achieve our goals. Oftentimes I find when I go around the country talking about contraception it’s almost viewed as a recreational drug, right? And maybe it’s the political climate we find ourselves in. But to realize how very important contraception is to women’s health, to the offspring’s health, and to society’s health is something that is usually unappreciated. So, I think it is numbers like this that wake us up to the fact that this is an important medical problem. Unregulated, uncontrolled fertility causes problems.

Almost 600,000 women worldwide will die this year from pregnancy and pregnancy-related causes. That number has gone up because obviously the number of women procreating has increased. That it is concentrated but not exclusively found in areas where access to resources are minimal. And if we look to see what women are dying of—the numbers are just as they read in the textbooks a hundred years ago—hemorrhage and obstructed labor, eclampsia. Another sort of insight into what the demand for family planning is, is that estimates are that every single day on the face of this earth somewhere between 75,000 and 80,000 women, young women, adolescents, attempt abortions. And of those, about 50,000 women are going to die on an annual basis. Now there is clearly an unmet need for contraception.

So as we’re looking at the impact in death and dying it’s clear. But it goes beyond that. UNICEF has let us know that every year there are about 15 million women who suffer long-term injuries and disabilities. And what I mean by long-term, it’s not postpartum when they have a sore little episiotomy or maybe they had a DVT but you come back a year after the delivery and their lives are, their health is disabled. The fistula clinics in Ethiopia clearly show that. But it’s beyond that. We have the hemiplegia from the eclampsia. We have all of these issues all together and put them all years together, estimates are there are about 300 million women on the face of this earth living with debilitating health problems that resulted from pregnancy and birth-related complications. Now to layer on to that, in the deaths and disabilities, the fact that fewer than half of the women wanted to be pregnant at the time that they conceived really lets us know how the burden of this problem is.

This is an older estimate; I love to cite my sources there. I got this from the LA Times. But it was a fascinating little trial that looked at analyzing the relationship between the utilization of birth control methods, the woman’s average birth over her lifetime, and her lifetime chance of dying from pregnancy and pregnancy-related causes. Now don’t tell anybody, but anybody here from Italy? Don’t tell the Pope but women in Italy do contracept. And we see that a woman’s lifetime risk at that time was about 1 in 17,000. In the United States, about 1 in 6,000, and my institution, Harbor/UCLA is about 131 north of the border so it’s easy for me to remember that in Mexico the lifetime risk of dying from pregnancy and pregnancy-related causes was about a little less than 1%. But there are countries where it’s a 1 in 7. So clearly these are major health problems. That’s from the mother’s standpoint. Now we all know that we can get better pregnancy outcomes if women plan and prepare for and in the setting of this conference, of course, this is one of the wonderful benefits that folks have when they have a little bit of infertility is they have to interact with the healthcare system and get the counseling about pre-conceptual care and you really do get these women in great shape for pregnancy.

What did this mom have before she got pregnant with this baby? What do you say? Diabetes. And we look at, from the waist up it almost looks like you ought to be playing for the Green Bay Packers. But this baby’s problem, of course, is sacral agenesis. And we know that our diabetic women who conceive when they’re in generally good control outside of pregnancy face about a 9% chance of having a major congenital anomaly. We’re talking cardiovascular or neural tube defect. If we get them into good control, glucose control, in the first trimester, we can drive that down to about 6 or 7%. But as you know, if they can get into good obstetrical glucose control before they conceive, the major congenital anomaly rate in those women is now less than that of the general population. In California we’ve had a Sweet Success Program going to reach out to our colleagues who care for these women and let them know how important pregnancy planning and preparation can be to the outcome of the pregnancy. And that’s been in place, the Sweet Success Program has been in place since 1985. But the last iteration, the last survey showed us in California 40% of diabetics who conceived did it by accident. So, again, our potential for making a huge difference in pregnancy outcome has not been achieved.

We know, just in general, people, not necessarily women with medical problems, that if you measure prenatal behaviors, whether they smoke or take their vitamins that there’s a significant difference in health habits in women who plan and prepare for pregnancy compared to those who either had a mistimed pregnancy or an unwanted pregnancy. So, again, making sure that we have really good prepared for moms makes a difference.

Since we have so very many, not only psychological-social, but medical reasons for planning and preparing for pregnancies, you’ve got to ask yourself why it is that women wouldn’t plan and prepare for pregnancies. This was an interesting issue that came out in 1997 from focus groups asking women exactly that question. And I think what’s fascinating, you can run through all of them there, but I thin in the context of this group the third bullet point is particularly interesting. If a couple announces that they’re trying to get pregnant and a whole year goes by and they don’t conceive then we all tend to label them as being infertile, don’t we? And you know what the psychological burden of that is. So having the disappointment there, obviously. The last one, I think some of you probably have had this, 16-year-olds wandering in. I’ve been having sex for three months and we haven’t gotten pregnant. Well are you trying to get pregnant? No, I just want to know if I can. Okay, it’s like if they get in the same room with the sperm they’re supposed to instantly conceive. So understanding probabilities is a hard thing when we talk about it.

This was even down and dirtier to the actual data. This was a survey that was done not only looked at the PRAMS, talking to people who absolutely did not want to be pregnant at the time they conceived but didn’t use any method of birth control with that active intercourse. Why didn’t you do that? You’re all parents and you understand some of the answers you get when they’re asked these questions. But if you total the first two numbers there, you can see that over 40% of the women who conceived when they didn’t want to but weren’t choosing any method of birth control didn’t think they were at risk for pregnancy. And I think we’ve all seen that in our practice. The other one that I think is very important if we’re going to make change is to recognize that 30% of those women were not really opposed to pregnancy they were ambivalent and I think that’s really the status where we find a lot of our patients today. If it happens, it happens; if it doesn’t, it doesn’t. And that’s just wonderful for dodging that infertility burden and that responsibility but it lets the benefits of pregnancy planning and preparation disappear through our fingers altogether. And we looked through some of the other issues that up there. I think those are real world reflections of what’s going on. But I think we typically underestimate ambivalence and we need to get our hands around that.

This was a study that we did in our clinic. It was published in Contraception and it looked at women who were contraceptive users, condom users. I’m in a Title X clinic and those of you who work in that know that we offer all methods of birth control. In Family Pact in California, all methods are totally free. If you get into my clinic you have to have less than 250% of the Federal poverty level and everything is totally free to you. So we send patients who decide they want to use condoms and sign the consent for them with a whole wheelbarrow full of condoms home with them with a packet of Plan B on top of it. And should they run out, they can always come back and pickup some more and if we’re not there than the little green card they have they just take to the pharmacy. So this is just about as good as it can be shy of my making house calls and delivering the condom to them at the right moment. So we ask people, you know who came back in for any visit, are you using condoms? Do you want to use them? So these are people who plan to keep using condoms as their method. Have you had any sex in the last 14 days? I thought one week might be too short, two weeks. And we found that of the women who had had acts of intercourse in the last two weeks, women who had had more than one active intercourse were more likely to less utilization of condoms. And so, what am I looking at? We’re looking at here women who had five or more acts of intercourse, 60% of them had had at least one active unprotected intercourse in the last two weeks. And even among the woman who were having one active intercourse, 30% of them had at least one active unprotected intercourse. So we asked them why.

And 44% said they didn’t think they were at risk. He withdrew, pulled out, took care of it, used rhythm, not at risk. They ran out, they didn’t have any condoms? Give me a break. I said, say what? Remember that wheelbarrow that we sent you home with? Remember that little green card? You try not to intimidate your patients but I actually got push back answers—well, it was in the other room. And it’s like you’re going to have to have something with Velcro or a staple to make sure that these things get used.

I mean these are real world insights into what’s going on. They forgot; they were lazy; they used something else.

Even in our Depo-Provera users we looked at over 1000 women who came in for a 3200 visits for injections. Of the women who came back for re-injections, at any one time, for the first three injects, second or third, 14 to 27% of them were late for their re-injections. So making sure that there aren’t any barriers can be there. And the continuation rates all the way up to the fourth re-injection are really low. So we have to recognize this as what the world we’re working with.

This is a study that we’ve just published looking at you had a unique access to some market information. And this may get it back to the world you live in rather than the public health world that I live in. This was access to 1.7 million women in the United States, 99% of all the retail pharmacies are in this database. And when a patient comes in and submits her first prescription for any method, she’s cranked in, and anywhere she goes in the country for a refill they can trace the refill. And the data analysis was looked at, if you came back within two weeks of the time, you fill the first one, did you come back within two weeks of the time of filling the first prescription to get the second or the third or the fourth. And to follow it out over time let me just get to the bottom line here. How many women using one-month methods, and many of them, even though you and I write prescriptions for a whole year’s worth, get them one month at a time? How many women came back for timely refills of their methods for a year? And here we found for the contraceptive rings it was slightly over a quarter, the patches were the same. Branded pills but they varied tremendously in their utilization. This pill here it was 16% of women came back for just one year. Depo-Provera was about 21% and, again the extended cycle ones, those tended to be higher. But this is dismal. So the woman may still think she’s using the method but she hasn’t come back on a timely manner to get her prescription. And we gave up to two weeks past the time that they needed their refill. And you know if you’re without your pills for two weeks you are at risk for ovulation. So this is today, this is the private sector; this is an amazing insight into what’s really going on.

This is not uniquely, this was a lovely paper that Murphy published earlier based on an insurance base study in a closed manage care. And, again, this is three months data, refills at three months were in the 50 to 60% range. So, utilization, you know if you have to go to the pharmacy to get a refill that’s a burden and there’s a lot of, at least temporary, discontinuation. And just because a woman goes to a pharmacy and picks up her supplies doesn’t mean she’s using them.

We all remember Linda Potter’s study here where she had a computer chip built in to the pill package and it would tell when the patient snapped the pill out, recorded the date and the time. And it was compared to the patient’s diaries of how they said they were taking their pills. And we can see here in green this is what women said. We had the first cycle, about 33% of women said I didn’t miss any pills whatsoever. I’m sorry, the diary said, over half of the women said that they missed no pills at all but big brother said it was only one-third. If you want to get really discouraging go out to the third cycle and here we have over 54% of women miss three or more pills on a monthly basis. So it’s not only that they don’t have the supplies on a routine basis but also when they do get them they’re not even utilized correctly and consistently.

So these are real world barriers that have lead to re-analysis of the data on how well in the real world, in typical use, what the failure rates are for our methods of birth control. And whereas DMPA should have a failure rate of three-tenths of one percent, we see the latest analysis shows us that 6.7% of women conceive while they’re using DMPA. Now they think they’re using it, but are they using it correctly and consistently? Oral contraceptives, you know we count on this as our gold standard and yet we’re finding nearly a 9% pregnancy rate amount OC users. Condoms has really slithered. Should be less than 2%. Used to be 12% and then it went to 15%, it’s now 17.4%, which is only one percentage better than withdrawal. So if you’re looking at it for STD protection as well as for pregnancy protection, we can see that we certainly haven’t captured all the potential that’s there. And fertility awareness, 25% pregnancy rate in typical use.

So what is going on? I think we’ve touched on a couple of themes that we want to talk about, ambivalence, fatalism, if it’s meant to happen, it’s meant to happen. Certainly an underestimation of fertility and an overestimation of the contraceptive risks, misinformation about mechanisms of actions. We have some system barriers and of course today everywhere around the world cost is such an important issue.

So as we’re approaching this, what could we do to close that gap if we could? And one of the most straightforward ways to approach this is to really give what David Grimes calls forgettable contraception, or reversible sterilization, where we offer women the implants and the IUDs that don’t require anything in terms of maintenance, by and large that they work without any input for a significant amount of time. And the typical use rates are very close to the perfect use rates. And in some cases, as we know in particularly younger women, these long-term, very effective methods actually are more effective than many of the methods of sterilization that we offer. So who is in this very top tier of efficacy?

Well the Copper T 380A has been up there for a while since 1988, since it came back in. And the prescribing information tells us that if you add up all the pregnancies for ten years you’re looking at somewhere less than a 3% cumulative pregnancy rate and this is real world. Expulsion, you and I know we can reduce if we avoid insertion on menses. And, of course, counseling really well about the bleeding and pain issues can help drive down the removals. After the first year we recognized that the number one reason ask to have the IUD removed is so that they can have another child. So that’s exactly what family planning is about.

These are newer data showing us that there’s actually evidence now for utilization of the same IUD up to 20 years. That there were zero pregnancies in any of the sub-populations that Sivin looked at for the Copper IUDs from the 10 to 20 year rate. So we can extend that off-label certainly very comfortably to 12 years and the newer data are indicating with small numbers that it may be very effective up to 20 years.

We’re all very pleased to have the single implant, Etonogestrel, effective for three years. In the United States we say that there were six pregnancies that occurred in 20,000 women’s cycles. But you probably all know the inside story on that that most of those occurred after removal of the implant. The FDA and that’s going to be one of the things, I’m sure Kurt and his group are going to talk about, that now when you put out a contraceptive you have to include any pregnancy that occurs within two weeks of cessation of the method cause we’re not really good at dating when the pregnancies occur. So, for the first time ever when we got those really good ultrasounds now we have to add uncertainty. It’s kind of like you use condoms for ten years, stop using them for two weeks, she gets pregnant, it must have been the last condom had a hole in it, right? But it does remind us that from these data that there’s a very rapid return to fertility, which gives women wonderful control over their own fertility. This works is a designer implant and helps address many of the issues women have around mechanisms of action. It was designed to inhibit ovulation. And we have very solid data, no ovulations for the first 30 months. So woman for whom that is an issue, this provides them secure evidence that they’re using as a contraceptive not an intraceptive.

LNG IUS, we are all very pleased to use. Again, similar efficacy is the Copper but as that whole extra dimension in terms of menstrual flow control, particularly helpful for women who have heavy menses or those who want to enjoy amenorrhea. So, again, superb. What about some of the others who may not be top tier but in terms that anything you can do to make the contraceptive easier, it will be used better?

And this was a classic study with a contraceptive patch where at every age group the women said, the patch users said they were more likely to use it on a weekly basis than the pill users were to take a pill on a daily basis. And when you got to the really young women, we really saw a huge difference in their perception of their utilization. And of course with the ring, the once a month ring, we’re very pleased to offer that because again that’s one of those forgettable contraceptives that provides so many benefits.

Well, as we’re looking at our role in offering contraception, this was a great proposal that came out from the ARHP that what we want to have is the most effective, safest method of birth control that will work well for the user. We want to be user centric. And as healthcare providers, we do have to very much consider the safety, the individual health profile of the woman who is coming to us but here we have mostly a veto power that if she is over 40 and she smokes, none of us is going to offer and estrogen containing method. We can talk about some of the non-contraceptive benefits that accrue to her health based on what we know about her various conditions. But by and large, most of what drives whether she is going to be successful or not and what’s going to work for her are these other things that have nothing to do with her health. It’s her lifestyle, can she remember to put her pill packet. When does she want to have another baby. When we talked about planning for pregnancies and preparing for them, because I have an excuse, I’m offering long-term methods as well as short-term, we actually do ask a question on our questionnaire, do you ever want to have anymore children and we offer sterilization if she says no and we don’t if she doesn’t. But then the followup question is if so, when do you want to have another pregnancy? And of all the questions that we ask on our questionnaire, that one is the most likely to remain blank. Sometimes they’ll just skip right over it and go to the other, they have no idea. If they do put something in I sometimes get an emphatic, well not now. Or I love the ones that go, when I get married. Well that’s a good idea too, right? But oftentimes, I’m not asking for a date, a time and a month. I’m really asking in terms of years or months. And the concept of pregnancy planning just isn’t there. So, again, in the context of choosing a method for them, maybe we can put in a little incentive to sit there and plan and prepare for. And then, again, the one thing that we hope is most amenable to education would be preferences. There’s so much misinformation out there. I’m sure you encounter it all the time too about the safety of methods and how well they work that we can actually provide better information and help influence them along those lines.

So what are our strategies for enhancing contraceptive success? Well I think that, again, as you do routinely, stress the benefits of planning and preparing for pregnancy, not only at each annual visit but golly when she comes in with a negative pregnancy test, we get them straight off the street, have you planned for. This is just a wonderful intervention point. Stress not only the risk that she's taking but talk to her about the health benefits, the non-contraceptive benefits that come with the hormonal methods. We know that acne is an approved, I’m sorry, three of the formulations in the United States are FDA approved for the treatment of acne. We know that we decrease blood loss. We can use certain formulations to decrease the number of scheduled bleeds. We can look at PMDD and pain from endometriosis and there's off-label information about decreasing even the episodes that women have bacterial vaginosis using some of the methods that we have out there. So finding out what her issues are and relating them back to her method may make her more successful in using the method.

This is a classic study showing us information about non-contraceptive health benefits. And we use these everyday but oftentimes patients aren’t aware that the reason that their periods aren’t as heavy as they were is because they’re on the pill.

Then, of course, this was the classic study, many of you remember this one, when we had women who had the acne and the study was published and they got the indication for the treatment of acne and young women who didn’t want to use those dangerous pills two weeks ago come clustered close to their little bosom bring you the tear out of the ad from their little teeny bopper magazine, oh I want the acne pill. What a great step forward in terms of patient acceptance, demonstrating that this did work better than placebo and the topical agents.

But what I really loved about this study is that they kept track of side effects for us. And this gave us, for the first time in about 20 years, a placebo controlled arm that we could use to measure side effects of a given contraceptive. Now when we’re doing efficacy studies, my IRB is a little fussy about that. Talk to them about can we put in a placebo arm. You’re coming in we want to see how well this pill is working, randomized to a sugar pill or to a contraceptive. But when you’re studying acne, everybody gets condoms, a lot of them weren’t even sexually active, so that wasn’t the issue and so you could actually see what happened to women during this six months when they took the active pill compared to the placebo. And this was, I think not surprising to us but probably would be to many women, this is what shows up in the FDA, the package insert but it doesn’t ever have this to balance it. So what was the incidence? Well during the six months of acne therapy, 18.4% of women who were on the pill got a headache, but 20.5% of placebo users did. And what was fascinating about this study is not one single one of these traditionally hormone related side effects achieved statistical significance. So I think there clearly are women who are sensitive to hormones and we want to respect that and respond to it but to warn women that they’re going to experience an increase in headaches or any of those other side effects, I think it’s not borne out by the data.

We have also the study from Yonkers showing us a new dimension of non-contraceptive benefits, the treatment of the physical and emotional of PMDD with a sort of a prolonged cycle of 24/4 formulation with drospirenone using 20 of ethenyl estradiol. Again, going into an area where it may be very important for a woman, linking that to her contraceptive so that even if she doesn’t necessarily, she breaks up with her boyfriend, she keeps on taking her birth control pill because it offers her these other benefits.

Then this wonderful study from Patsy Sulak that helped us pinpoint that when women were miserable on the pill it generally wasn’t when they were taking the active pills but when they were taking the placebos. And that led us into this concept of shortening the pill-free interval or eliminating it for extended periods of time. So I think this was very helpful and, again, addressing women’s issues and bringing the insight to us so we can make the product change. This was a cyclic use of the pill at 21/7 and then they gave them extended cycle with this and you can see that the symptoms, the problems that women had, the headache score, the mood score and the pelvic pain score all peaked during the placebo days but all were back to baseline when women continued to use it on an extended cycle. So it’s not brand necessarily, again this reminds us how very important the way we’re administering contraception can be to women.

Well what about other health benefits? This is a classic study in women who have sickle cell anemia and showing us that oral contraceptives and the injectables significantly reduced active acute crises. So not only for women who have sickle cell anemia and need to hold onto their blood and don’t want to be wasting it with a menses, the amenorrhea given by the injections can be very important there. But also dealing with their underlying pathophysiology can be very important.

And, we had, this may be more relevant to you but the depo sub-Q actually carries as an indication the treatment of pain from endometriosis because along all of these different parameters within endometriosis, this was very successful in reducing the pain scores that women had. So as an alternative to some of the other agents that we generally prescribe this can provide contraception on an ongoing basis and also relief from some of the pain from endometriosis.

So what else can we do to motivate couples? Well, show them their methods and it’s accessories that somehow rather tease them with this that it can enhance sexual pleasure. And we have some baseline stuff that we all know the vaginal ring increases vaginal lubrication. In the clinical trials it was labeled lucorea. I talk about it as lubrication and that makes it sound so much better. Traditionally, condoms have just not been very sexy, have they? I mean they’re cold. You have to open up a foil package, interrupt all of the love making pleasure, all of this type of stuff and what has happened is that the companies have realized that people out there have gotten message that they should use condoms but nobody really wants to. So this whole new commercial waves that you’re seeing around to increase their appeal and to even accessorize male condoms. Have you guys seen the new accessories that come out with these? I’ll share one.

Well it cuts back to the basic thing. There used to be a concern that condoms didn’t fit all men. And after I saw Sharon with a condom on her head I thought that was probably wrong. But it turns out that Sharon and I were wrong.

Surveys have shown us that about 6.6% of American men cannot comfortably fit into the normal size condom. So there has been a whole array of different sizes of condoms that are out there. If you require extra room from the top all the way to the head then there are all these different brands and where do they get these names—Magnum XL? Okay. And of course, very importantly the polyurethane condoms, the Avanti and the Trojan Supra are important to us for people who have latex allergies. Well what if you just need a little bit more head room, the shaft isn’t all that big, well then they have all these delights for you. Now you might ask what is Trojan Her Pleasure? Well it is a normal condom with a baggie on the top, okay, to give him plenty of head room and they thought that that little extra bit of plastic flapping around at the top of the vagina would drive her crazy and that’s how they get that name. If it were only that easy, right? Well then we have another problem. And that is, what about the guy who isn’t a Magnum XL? What if he tries to use condoms and they just fall off and some of the later more recent information coming from the CDC wrenches your heart out. Going to high schools and talking to kids not the ones who’ve dropped out but the ones who were still in high school, the most recent survey shows us that 7% of those young men starting having coitus before age 13. Yes, you guys were all nerds and that never happened, I know, but it’s out there. So what are we going to do for those guys? Some of them may not have achieved all of their secondary sexual characteristics and if they try to do the responsible thing and keep their teachers from getting pregnant than they need a condom that fits. And so I tried to come up with names. I’m obviously in the wrong business. Little Guy—that’s not going to work. Girls Who Wear Trainer Bras, but that doesn’t work for condoms. The answer is Snugger Fit and this is very important because these are ones that will adhere and for the non Magnum XL guy letting people know that there are ranges of sizes that will work very well for all of them

And these are real excuses that came from not my clinic but from the Planned Parenthood down the road. Number one reason for not using a condom is I didn’t know him well enough to ask him to use one. Anybody from Kansas? Well I think number five is the most frank—We don’t like them. And we have a real problem with condoms, they don’t look very sexy and even though we have surveys that show us now, online, more than half of condoms are bought by women, in stores about 30% of condoms. They’ve done time motion studies where the women come up to the condom area and where are condoms generally sold? In the man’s part of the store. And women don’t linger there to do comparative shopping. If you’re going to make a big difference in how women buy condoms you’ve got to get it in the safe part of the store. And where’s the safe part of the store for women? Where you guys feel threatened. Where do you run up real fast grab the pads and get out of Dodge as fast as you can. So it’s by the sanitary protection and that’s where they’re beginning to put male condoms, and this is just an example of one that’s there.

This is a male condom and they’re giving you all kinds of things. And now what are they doing, they’re accessorizing it. It comes with what? A refreshing wipe. Many of you may have seen commercials that they have for lubrication and the man is rubbing it into the woman’s shoulder and she’s just melting in his fingers. That’s not where that goes, okay? And the penultimate accessory that has come out is a vibrating ring. I don’t know if you’ve seen this. It’s illegal in eight states and they won’t sell it in Walmart but it is going like gangbusters elsewhere. It is a ring that fits at the base of the male condom and it has a battery operated little vibrator that sits there and they now have second generation of these. There’s a vibrator on either side so you don’t have to fight over the vibrator. Anyway, so they are trying to change the image and make condoms more fun to use and reward their use. And, again, if we think about rewarding the use before contraception, tying it to the dysmenorrhea and maybe even the pleasure of the moment.

Other things we can do is we recognize some real world barriers and in our own practices we can try to chop some of those down and make it easier for people to be successful. And in this category I’ve put in the new developments that are out there for same day or quick start. Offer extended cycle methods to again try to reduce the number of times she has to come back and beg at the pharmacy for refills. Provide as many cycles of supplies as you can. Anticipate the impact of sticker shock on contraceptive behavior. I’ve talked to a lot of pharmacists who say the women come up to their tables and turn in their prescriptions, they hear how much it is and they say oh I can’t get that today. So find out what the woman’s insurance coverage is, what her abilities are. We have a wide range of different formulations. And I know even the generics are very expensive today but clearly we need to let her find one that she can afford to make it work. And, in this country, I’m hoping not elsewhere, but there are some contraceptive unfriendly pharmacies and we’ve got to make sure that we’re letting women go to the ones where they can get the service they need.

So what is Quick Start? She’s here today and she starts any of the hormonal methods she wants to start. So she starts the first pill in the pack or give her the Depo-Provera or you can place the Copper IUD. It has studies, this gets around the study that Carolyn Westhoff did that shows that about a quarter of the young women in her practice, when she gave them a prescription and said fill it or even when she gave them the pills, start your pill with the first day of your next period, 25% never started it, either because they got pregnant or they changed their mind or they didn’t quite remember how to take it if they went through all the pill—you by the time you get down to how to take the pills in the packages or you’ve found seventeen different ways it’s going to kill you and you probably don’t want to start the pill. And then their friends, of course, telling them how bad this is for them. If you’re going to do Quick Start then you do start with the first pill in the package. You provide backup method for at least seven days. And then of course you have to cover what’s happened most recently. If she’s had unprotected intercourse in the previous five days then want to be offering emergency contraception. And the timing of the starting, typically what I’ll do with the ring and the patch and Depo, I’ll give EC plus that method at the same time. When I’m giving oral pills, because the absorptions are so high I may delay the starting of the pill for 12 hours after she’s taken EC.

Does it increase spotting and bleeding, you think it was if she’s already gone through the follicular phase but wonderful studies have demonstrated that there is no increase in unscheduled spotting or bleeding if you do a Quick Start compared to a first start pills. And what Carolyn found first off was that with the teens you come back in three months and the continuation rate is much higher.

We’ve now had a longer controlled trial of women under 25 and found that they did, if you started them today, they were good going into the next cycle. But you went even three cycles and it made no difference in the Quick Start versus controls. 60% of all the users discontinued OC use. So we’re going to have to take these in little baby steps. But anything we can do to decrease barriers today. And 81% of the women rated the Quick Start as acceptable or preferable to the usual one.

There is one that we did with Depo-Provera. I think I alluded to that earlier that, of course, women don’t come in on their menses to get their Pap smear so virtually every women, if you didn’t do a Quick Start on Depo-Provera, we’d be told to come back next cycle to get her injection. So we increase the utilization that first month by 80% by allowing the Quick Start with the Depo and it made no difference, I mean we didn’t have any significant problems with it.

Quick Start ring versus the pill—you get excellent cycle control and, of course, the benefits that come from placing a ring while she’s in the office doing the Quick Start is that you can show her, make sure she knows how to place it and remove it and she gets all those big questions that are lingering in her mind—will it fall out? Won’t I feel it? Okay, there’s the third question that’s always there; won’t he feel it? That’s homework; they don’t do that in my clinic. But clearly this works.

Extended cycle pills. We all feel very comfortable about these because not only does this get rid of the unnecessary bleeding that women have on a scheduled basis with the traditional 21/7 but it also allows her three whole packs of pills at a time in some of the formulations that are there.

So we know that the median number of days of unscheduled spotting and bleeding drops distinctly after the first cycle and we just need to get her through that altogether.

Here’s a trial with a contraceptive vaginal ring. This was off label but we did every three weeks changing the ring and it worked very well. We got a little bit more spotting and bleeding toward the end so choosing an interval that works well for a patient can be very helpful.

We want to make sure that she understands what it means when her period doesn’t come down. We know that we want in explaining this we really want to validate everything she understands about the normal sea of the menstrual cycle but then change the paradigm for her, that the blood is not building up, her ovaries aren’t swelling, her fertility will return and her cancer risk is not increased. I mean those are some of the common questions we get oftentimes with the extended use.

If you give people more cycles, I know it makes like you should know this offhand, but it’s always good to have evidence to show it. Continuation rates are definitely increased if you give people more cycles of birth control methods. When they come back they’re more likely to be continuing them. And we looked at all methods, OC users and patch users and in every one and achieved statistical significance.

Finding pharmacies and this is one of my favorite little cartoons here. There’s a pharmacist saying I’m sorry lady, I’m morally opposed to birth control pills and I’m sure you’re running into some of that in your community. But definitely we want to make sure that women are aware that there are, you know don’t go in there and try to fill it there.

And then anticipate problems. I think to be successful we know that women are going to run into problems. And one thing Bob Hatcher has taught me is not only spend as much time as you can teaching her about the method that she wants to use today but also the backup method in case she stops using the pill, does she know how to use a condom. We assume that it is somewhere on the Y chromosome. I know it’s not on the X chromosome but going out there and teaching young men maybe that kind of knowledge about how to use condoms blossoms later in life but it is something that is a learned experience. So making sure they know how to use their backup. Give EC routinely by advanced prescription. I know it’s available behind the counter across the country but oftentimes that’s not picked up by her insurance company. So if we give her that little safety net that can be important to her. And explain the mechanisms of action based on evidence not conjectures.

We have these wonderful data from Alvarez way back when, when he got the eggs from the women who had had mid-cycle coitus wanting sterilization and showed that in none of the IUD users was there normal development of the ovum. But 50% of the women who had mid-cycle coitus showed fertilization.

And most recently, the data that’s come to us from emergency contraception rather than relying on the woman’s last menstrual period to say where she is in her cycle, actually looking, drawing her serum levels for LH, estradiol and progestin to time exactly where she is in her cycle when she swallows the pills so we can understand how it works. And we can see using the usual distribution of pregnancies that given the women who came in, where they were in the cycle, this population of 99 women who had intercourse from day –5 to –2 and EC was taken before day 1 on or before, they expected 4 to 5 pregnancies. And of the women who took it after ovulation they expected 3 to 4 pregnancies. And what they got was no pregnancies if the pill was taken before ovulation and 3 pregnancies, just what we expected, if it was taken after. So this really shakes our beliefs that there must be a luteal component to this, which would mean interception instead of contraception. So you scratch your head. It’s kind of like after the WHI we said wait a minute how could those answers be so much different than we saw in the observational studies. You’d really like to integrate all the knowledge that you’ve had. And it was interesting because the same group looked at the data based on the woman’s LNP and found that 53% of the women who thought that they were in the luteal phase really were in the peri-ovulatory phase. So if we’d done this analysis based on LNP we would have thought there had to be a luteal component.

All right, so, in sort of looking forward, what else can we do? Well let’s be patient. We know that the answer we come up with today may not be good for her tomorrow. There may be new things that come in. So we want to be willing to change with women over time. We certainly want to keep up to date and that we have to be patient to understand that consistent and correct use of any medication, particularly for an asymptomatic condition is usually very dismal. So that women are actually doing very, very well with birth control pills compared to anti-hypertensive medications and we need to give them credit

We want to find out what it is that she will use. We want to make it attractive. We want to start it now. We want to giver her EC now, if she needs it and certainly for future use. We want to give gobs and gobs and gobs of contraception if we can and a backup method and to help her plan and prepare for pregnancy in the future. So in summary, now and lots and more.