Post-authorization surveillance study comparing the efficacy and safety of Medabon (mifepristone/misoprostol) to historical data for early pregnancy termination (Medabon PASS)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Open-label, non-interventional, prospective, observational, post-authorisation study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  MIFEPRISTONE

  MISOPROSTOL
• Medical condition to be studied:
  Abortion induced

Population studied

• Short description of the study population:
  Consecutively treated pregnant women with 63 days or less of gestation, requesting abortion and eligible for legal termination of pregnancy who have received Medabon per institutional practice and according to the European SPC, who are not participating in another interventional trial, and who are able to provide written informed consent.
• Age groups:
  • Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To collect descriptive outcome data on the rate of incomplete abortion and continuing pregnancy, as well as the rate of adverse events related to the use of Medabon, in women requesting medical abortion with 63 days or less of gestation, as an additional pharmacovigilance measure in the risk management strategy for Medabon in Europe.
• Outcomes:
  The primary variable is the rate of incomplete abortion and continuing pregnancy at the time of the follow-up visit (10 to 14 days after the administration of mifepristone), the requirement for subsequent surgical evacuation, and the requirement for emergency evacuation due tohaemorrhage or other reasons. Secondary outcome variables include the incidence of AEs related to Medabon, and the necessity for additional medical treatment related to the termination of early pregnancy, such as the use of antibiotics to treat genital infections.
• Data analysis plan:
  Frequency of AEs, SAEs and outcome variables will be summarized by body system, preferred term, and relationship to Medabon.On reaching 500 subjects, descriptive statistics and data listings will be used to summarize the data for the purposes of review by the sponsor. Adequacy of the risk management strategy for Medabon in Europe and the impact of risk management interventions will be assessedthroughout the study. On completion of the study, the final study report and Risk Management Plan for Medabon in Europe will be provided to the EMA.