Mifepristone for uterine fibroids

Bioequivalence Study of Two Formulations of Mifepristone Tablets in Healthy Chinese Subjects Under Fasting Conditions

“…The AEs of mifepristone are usually minor and mild. The most frequently reported AEs in the previous clinical studies included nausea, vomiting, diarrhea, headache, dizziness, weakness, and fever/chills 6 . Among these AEs, only diarrhea occurred in our study.…”

“…The most frequently reported AEs in the previous clinical studies included nausea, vomiting, diarrhea, headache, dizziness, weakness, and fever/chills. 6 Among these AEs, only diarrhea occurred in our study. TEAEs with an incidence of more than 10% included increased blood bilirubin and hypotension in our study, which may not be related to mifepristone.…”

Bioequivalence Study of Two Formulations of Mifepristone Tablets in Healthy Chinese Subjects Under Fasting Conditions

“…The AEs of mifepristone are usually minor and mild. The most frequently reported AEs in the previous clinical studies included nausea, vomiting, diarrhea, headache, dizziness, weakness, and fever/chills 6 . Among these AEs, only diarrhea occurred in our study.…”

“…The most frequently reported AEs in the previous clinical studies included nausea, vomiting, diarrhea, headache, dizziness, weakness, and fever/chills. 6 Among these AEs, only diarrhea occurred in our study. TEAEs with an incidence of more than 10% included increased blood bilirubin and hypotension in our study, which may not be related to mifepristone.…”

Role of Mifepristone in Conservative Management of Fibroids

“…At the end of study, a significant improvement in symptoms affecting the quality of life of patients was observed and except for one patient complaining of abdominal pain no other complication was reported. It is well documented that mifepristone, in low dosages, improves the quality of life of patients [13][14][15][16] and given the fact that in present study no side effect was reported even after using a 50 mg protocol, the significance of results assumes more importance that weekly administration of oral mifepristone improves the quality of life of patients and keeps the side effects under check comparable to those for low-dose protocols (5 to 10 mg).…”

Gonadotropin-releasing hormone analogues inhibit leiomyoma extracellular matrix despite presence of gonadal hormones

“…Modulation of collagen metabolism, in leiomyoma cells, by E has been demonstrated (55,56). Use of selective ER modulators (e.g., raloxifene and tamoxifen) (57) and selective PR modulators (e.g., asoprisnil and ulipristal acetate) (17,42,43,45,47,58) support the data that E and P play a role in collagen production. Exposure to both GnRH-a significantly decreased the COL1 protein within 24 hours, supporting the fact that both are known to clinically decrease the leiomyoma volume.…”

Bioequivalence Study of Two Formulations of Mifepristone Tablets in Healthy Chinese Subjects Under Fasting Conditions

“…The AEs of mifepristone are usually minor and mild. The most frequently reported AEs in the previous clinical studies included nausea, vomiting, diarrhea, headache, dizziness, weakness, and fever/chills 6 . Among these AEs, only diarrhea occurred in our study.…”

“…The most frequently reported AEs in the previous clinical studies included nausea, vomiting, diarrhea, headache, dizziness, weakness, and fever/chills. 6 Among these AEs, only diarrhea occurred in our study. TEAEs with an incidence of more than 10% included increased blood bilirubin and hypotension in our study, which may not be related to mifepristone.…”

Role of Mifepristone in Conservative Management of Fibroids

“…At the end of study, a significant improvement in symptoms affecting the quality of life of patients was observed and except for one patient complaining of abdominal pain no other complication was reported. It is well documented that mifepristone, in low dosages, improves the quality of life of patients [13][14][15][16] and given the fact that in present study no side effect was reported even after using a 50 mg protocol, the significance of results assumes more importance that weekly administration of oral mifepristone improves the quality of life of patients and keeps the side effects under check comparable to those for low-dose protocols (5 to 10 mg).…”

Gonadotropin-releasing hormone analogues inhibit leiomyoma extracellular matrix despite presence of gonadal hormones

“…Modulation of collagen metabolism, in leiomyoma cells, by E has been demonstrated (55,56). Use of selective ER modulators (e.g., raloxifene and tamoxifen) (57) and selective PR modulators (e.g., asoprisnil and ulipristal acetate) (17,42,43,45,47,58) support the data that E and P play a role in collagen production. Exposure to both GnRH-a significantly decreased the COL1 protein within 24 hours, supporting the fact that both are known to clinically decrease the leiomyoma volume.…”

Bioequivalence Study of Two Formulations of Mifepristone Tablets in Healthy Chinese Subjects Under Fasting Conditions

“…The AEs of mifepristone are usually minor and mild. The most frequently reported AEs in the previous clinical studies included nausea, vomiting, diarrhea, headache, dizziness, weakness, and fever/chills 6 . Among these AEs, only diarrhea occurred in our study.…”

“…The most frequently reported AEs in the previous clinical studies included nausea, vomiting, diarrhea, headache, dizziness, weakness, and fever/chills. 6 Among these AEs, only diarrhea occurred in our study. TEAEs with an incidence of more than 10% included increased blood bilirubin and hypotension in our study, which may not be related to mifepristone.…”

Role of Mifepristone in Conservative Management of Fibroids

“…At the end of study, a significant improvement in symptoms affecting the quality of life of patients was observed and except for one patient complaining of abdominal pain no other complication was reported. It is well documented that mifepristone, in low dosages, improves the quality of life of patients [13][14][15][16] and given the fact that in present study no side effect was reported even after using a 50 mg protocol, the significance of results assumes more importance that weekly administration of oral mifepristone improves the quality of life of patients and keeps the side effects under check comparable to those for low-dose protocols (5 to 10 mg).…”

Gonadotropin-releasing hormone analogues inhibit leiomyoma extracellular matrix despite presence of gonadal hormones

“…Modulation of collagen metabolism, in leiomyoma cells, by E has been demonstrated (55,56). Use of selective ER modulators (e.g., raloxifene and tamoxifen) (57) and selective PR modulators (e.g., asoprisnil and ulipristal acetate) (17,42,43,45,47,58) support the data that E and P play a role in collagen production. Exposure to both GnRH-a significantly decreased the COL1 protein within 24 hours, supporting the fact that both are known to clinically decrease the leiomyoma volume.…”