And what are the appropriate approaches to address that. And as a medical group, I think as a group, they’ve been, it’s frustrating that there are not as many options as one would hope to address these conditions. And these symptoms that are very debilitating in terms of a women quality of life and her ability to function, right? We joke about hot flashes but the disruption to the sleep and the downstream consequences that are a big deal. But there’s other factors that happen in women when the hormones deplete, right? So there are factors related to bone health. There are factors related to cardiovascular health. So hormone therapy as a North American menopause study say, can play a very important role. But the objective is you really want to deliver hormones, particularly the estradiol at the lowest possible dose that you can to still see beneficial effects and you want to counterbalance it for safety with progesterone.
So you really want the 2 hormones together. And clinicians have been a little bit limited as they haven’t had. And ideally, because these hormones are not efficiently metabolized through the oral route to — and therefore, you have to give really higher doses, right, when you’re dosing orally and non-oral route can have benefits but you really want both hormones So we’re excited about HRT1 because there’s not been a product yet that does that in this convenient once a month, both hormones together, vaginal form, you’re delivering them in that route administration. So very much an unmet need. And very excited about a product that can address that unmet need and excited to have the opportunity, hopefully, to deliver something that is aligned with what the North American Menopause Society position paper on menopause indicates may have a lot of value.
Now having said that, to your question on what do we see? Why are we excited? Well, we’re excited. Obviously, that’s a form factor for all the reasons I said. But with hormone therapy, we know, right, with hormone therapy, we know the levels that you want to see. We know them for 2 reasons. We know them because of the products that are already FDA approved and have demonstrated benefits. So you can go through 1 exercise and just look at our levels and compare them at FDA-approved products to say, okay, check, yes, we’re delivering it out like that product. But also importantly, what you’re doing with hormone therapy is you’re replacing the hormones that she no longer has. And we know what targets we want to replace. We want to get it to a certain part of her cycle in the premenopausal phase, right?
We set certain levels of format, not the high levels that she has when she’s ovulating but the low levels that she has at certain phases of recycle. So the PK data basically allow us to see that. They allow us to make that comparison to see yes, we’re at low doses but look, we’re at effective levels because we know what it’s been achieved with some other products and their form factors, what they’ve seen systemically. And then we also know our target is to what you want to achieve in the premenopausal women. So for all those — that’s why we are so thrilled and obviously thrilled with the significance we saw, even though it was a small study, the fact that we were able to exhibit that level of improvement. In terms of what we need to do, though and so therefore, we were thrilled in the pre-IND discussions with the FDA that this path of going to a single Phase III is an option for us.
What that means now is we have to execute against that. So from a manufacturing perspective, obviously, we’ve got to manufacture the GMP product for the Phase III trial. And so there are, obviously, activities underway to support that to be able to support those supplies being ready for the Phase III. And then similarly, having — the reason you have pre-IND discussions is to clarify what is expected in the IND. And there’s some nonclinical work that we will need to do as well to support that for the IND. So all of that work is underway. What I wish I could do for you today but I can’t yet but we look forward to giving that update when we can is tell you the exact time line. Like so what does that mean in terms of when exactly we expect to be in that Phase III study.
