Drug products: Mifecur, Mifegyne, Mifepristone Linepharma®
ATC code: G03XB01
Mifepristone is approved on indications concerning prevention or termination of pregnancy and therefore analyses of sex or gender differences are not relevant. Mifepristone is also used on other indications but published data with relevant sex or gender analysis are sparse.
Mifepristone is a synthetic steroid blocking progesterone . It is approved on the indications induction of abortion during first trimester (in combination with prostaglandins), post coital contraception and cervical ripening prior to suction termination of pregnancy [1-3]. For these indications the substance is only used in women and analyses on sex or gender differences have therefore not been considered relevant.
Mifepristone has also been studied in Cushing’s Disease in patients with ectopic ACTH-secreting neoplasms or adrenocortical carcinoma to control hypercortisolism while waiting for definitive therapy [4-6]. Both men and women have been included in the studies but no analysis of sex differences has been found even though Spitz et al report sex divided data . Clinical studies of the effect of mifepristone on neuroleptic induced weight gain have been performed in men, thus sex-divided analysis in this therapeutic area is also lacking [7, 8].
No studies with a clinically relevant sex analysis regarding pharmacokinetics and dosing of mifepristone have been found.
No studies with a clinically relevant sex analysis regarding effects of mifepristone have been found.
Controlled studies on adverse effects between men and women in mifepristone safety are lacking although there is one study presenting sex-divided data on adverse events in treatment of Cushing Disease .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2017-04-11
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson