ReachMD

Announcer:
Welcome to Advances in Women’s Health on ReachMD. On this episode, we’ll hear from Dr. Mitchell Creinin, who’s a Professor in the Department of Obstetrics and Gynecology as well as the Director of the Complex Family Planning Fellowship at the University of California Davis Health. Dr. Creinin is here to share key findings from his research that was presented at the 2023 ACOG Annual Clinical and Scientific Meeting, which evaluated heavy menstrual bleeding outcomes with IUD use. Let’s hear from him now.

Dr. Creinin:
This study was designed to be a phase three approval study for the use of LILETTA, the leading industrial 52 milligram IUD for the treatment of heavy menstrual bleeding. So this study was designed to meet the criteria necessary for regulatory authority approval.

This study was just a single cohort study where we enrolled women who complained of heavy menstrual bleeding, and then they went through a screening process where they collected their menstrual products for up to three screening cycles, where the products were then analyzed to get an idea of how much blood they were actually losing. And as long as the total amount was at least 80 milliliters or more, they could then get the IUD and continue to be evaluated for what the effects of the IUD would be on their bleeding over up to approximately six months.

So this study provides important data in a contemporary population because the studies that have been done before where we actually collected menstrual products were done many years ago in a different kind of population. The prior studies only allowed Paris women into the studies, and they didn't include women that had a BMI over 35. And we know that over 40 percent of the US population is obese now. And so the information that was lacking in the literature was how does this product work in today's world, as far as decreasing bleeding? And how does it work in populations, which have women that we typically see, which includes people who have never been pregnant before, as well as people who are significantly obese?

So the first thing that we found that's most important is that there's a very rapid decrease in blood loss and a significant decrease in blood loss; within three cycles, the amount of blood that people were losing per cycle decreased by about 90 percent. And by six cycles, it was more than 95 percent. So this is a really dramatic change for people that were losing very significant amount of blood with every menses; their flow was decreased to the point where it was about two teaspoons or less total for a whole month. Keep in mind that hormonal IUDs don't result in people having regular cycles. So during the screening period, we were having women collect their menses pads and tampons or whatever they use during their menses. Whereas part of the study evaluations during cycles three and six, it was any products to use for the entire cycle for an entire four-week period. So when you look at bleeding over a week or so versus a whole almost-month, the amount of decrease in blood flow is really dramatic. The other thing we found is that because we had very significant numbers of Nola-Paris and Paris women comparatively as well as women who were obese and non-obese, there was no difference at all in the outcomes, regardless of their characteristics, so this effect is seen for all women, and not just in some women, keeping in mind that all the prior studies really only looked at does this work in women who were in Paris and who were not very obese.

Announcer:
That was Dr. Mitchell Creinin talking about his research that was featured at the 2023 ACOG Annual Clinical and Scientific Meeting. To access this and other episodes in our series, visit ReachMD.com/AdvancesInWomensHealth, where you can Be Part of the Knowledge. Thanks for listening!