madman
Super Moderator
* Winter explained that for a hormone replacement therapy to receive FDA approval, it must demonstrate safety and appropriate pharmacokinetics—specifically, its ability to raise hormone levels. Unlike other drug approvals, efficacy data is not required, as there is broad clinical consensus that restoring essential hormone levels is critical to overall health.
www.urologytimes.com
Ashley G. Winter, MD, reflects on the need for FDA approved testosterone formulations in women, emphasizing that urologists are well-positioned to drive change in this space.
The FDA recently convened a panel of experts to discuss the current landscape of hormone replacement therapy in women.1 During the discussion, Kelly Casperson, MD, highlighted a key gap in care: the lack of FDA-approved testosterone formulations for women.
In a recent interview with Urology Times®, Ashley G. Winter, MD, a board-certified urologist in Los Angeles, California, emphasized that urologists are well-positioned to drive change in this space.
She said, “I think as urologists, we should be very interested in this topic, because we are the champions of testosterone. We have guidelines on testosterone use. Unfortunately, at the current time, they primarily apply to cisgender men, and I think we can do a lot better than that.”
Winter explained that for a hormone replacement therapy to receive FDA approval, it must demonstrate safety and appropriate pharmacokinetics—specifically, its ability to raise hormone levels. Unlike other drug approvals, efficacy data is not required, as there is broad clinical consensus that restoring essential hormone levels is critical to overall health.
Winter concluded, “I truly hope that this issue is revisited, and I also hope that urologists take a front seat in championing testosterone replacement for women as a professional organization, in our guidelines, and in our education.”
Ashley Winter, MD, discusses testosterone therapy for women
Ashley G. Winter, MD, reflects on the need for FDA approved testosterone formulations in women, emphasizing that urologists are well-positioned to drive change in this space.
Ashley G. Winter, MD, reflects on the need for FDA approved testosterone formulations in women, emphasizing that urologists are well-positioned to drive change in this space.
The FDA recently convened a panel of experts to discuss the current landscape of hormone replacement therapy in women.1 During the discussion, Kelly Casperson, MD, highlighted a key gap in care: the lack of FDA-approved testosterone formulations for women.
In a recent interview with Urology Times®, Ashley G. Winter, MD, a board-certified urologist in Los Angeles, California, emphasized that urologists are well-positioned to drive change in this space.
She said, “I think as urologists, we should be very interested in this topic, because we are the champions of testosterone. We have guidelines on testosterone use. Unfortunately, at the current time, they primarily apply to cisgender men, and I think we can do a lot better than that.”
Winter explained that for a hormone replacement therapy to receive FDA approval, it must demonstrate safety and appropriate pharmacokinetics—specifically, its ability to raise hormone levels. Unlike other drug approvals, efficacy data is not required, as there is broad clinical consensus that restoring essential hormone levels is critical to overall health.
Winter concluded, “I truly hope that this issue is revisited, and I also hope that urologists take a front seat in championing testosterone replacement for women as a professional organization, in our guidelines, and in our education.”
