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Re: DewDiligence post# 217394

Wednesday, 02/21/2018 9:02:17 AM

Wednesday, February 21, 2018 9:02:17 AM

Post# of 257484
I am not following the development of this drug at all so with that caveat this study has some curious features to me. The first is that birth control pills (often given continuously without a withdrawal bleed) is the most commonly employed first line treatment for bleeding, even bleeding associated with fibroids. So there was no positive control - at least what is used in the real world. Moreover low dose add back with combined estrogen progesterone was used for BMD preservation as is standard for drugs like lupron, but this could have affected amount of bleeding and clouded the drug effect to some degree.
Meds that suppress hormones like lupron are also not usually thought of as chronic treatment for fibroids because of the long term side effects (and actually only usually given for about 3 months without add back just to increase HCT prior to surgery or shrink fibroids a bit to make certain surgical approaches viable or easier like hysteroscopy or laparoscopy). I wonder if they are trying to alter that paradigm and position the drug for long term management of fibroids if they can thread the needle and get adequate efficacy without affecting BMD long term?

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