Efficacy Trial 1 will have 450 participants and 131 study sites.
https://www.clinicaltrials.gov/ct2/show/NCT04003142?term=Fezolinetant&draw=2&rank=1
Efficacy Trial 2 will have 450 participants and 128 study sites.
https://www.clinicaltrials.gov/ct2/show/NCT04003155?term=Fezolinetant&draw=2&rank=2
Safety Trial will have 1149 participants and 194 study sites. Evaluating endometrial thickening and risk of endometrial cancer, and bone density evaluation. Will take 52 weeks to evaluate each patient. "Undergo an endometrial biopsy at screening and at week 52", and from experience I know those are painful!
https://www.clinicaltrials.gov/ct2/show/NCT04003389?term=Fezolinetant&draw=2&rank=3
If the company has to wait for approval for the Safety study to be completed, it may be a while for a study that large and that long of a follow period to be finished.
https://www.clinicaltrials.gov/ct2/show/NCT04003142?term=Fezolinetant&draw=2&rank=1
Efficacy Trial 2 will have 450 participants and 128 study sites.
https://www.clinicaltrials.gov/ct2/show/NCT04003155?term=Fezolinetant&draw=2&rank=2
Safety Trial will have 1149 participants and 194 study sites. Evaluating endometrial thickening and risk of endometrial cancer, and bone density evaluation. Will take 52 weeks to evaluate each patient. "Undergo an endometrial biopsy at screening and at week 52", and from experience I know those are painful!
https://www.clinicaltrials.gov/ct2/show/NCT04003389?term=Fezolinetant&draw=2&rank=3
If the company has to wait for approval for the Safety study to be completed, it may be a while for a study that large and that long of a follow period to be finished.