Report on Repeated Mifepristone Treatment for Uterine Fibroids or Endometriosis

Abstract

Background: No information is available on how repeated administration of mifepristone could affect womens health.

Methods: A total of 101 and 36 subjects who participated in up to 2 and 3 mifepristone trials to treat endometriosis or uterine fibroids, respectively, carried out at the Eusebio Hernandez Hospital, Havana, Cuba.

Results: Subjects who repeated mifepristone to treat fibroids did so for 7.3 2.5 months, minimum and maximum of 6 and 15 months, respectively. The average rest interval was 9.7 6.2 months, minimum and maximum of 3 and 30 months, respectively. In subjects repeating mifepristone for endometriosis, the average was 18 2.0, with a minimum and maximum of 12 and 24 months, respectively. The average rest interval was 8.3 5.3 months, 95% CI = 7.6 - 8.9, minimum and maximum of 3 and 30 months, respectively. No change in womens health was detected months after termination of final mifepristone treatment.

Conclusions: Repeating low doses mifepristone treatment up to 3 - 4 times for 3, 6 or 9 months duration with variable rest intervals between sessions, did not seem to involve any risk to health. More studies to confirm the long-term safety of repeated low dosage mifepristone are mandatory.




doi: http://dx.doi.org/10.4021/jcgo148e