Post-Authorization Safety Study (PASS) of conjugated estrogens/bazedoxifene (CE/BZA) in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46641
• EU PAS number:
  EUPAS11599
• Study ID:
  46641
• Official title and acronym:
  Post-Authorization Safety Study (PASS) of conjugated estrogens/bazedoxifene (CE/BZA) in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Compare the incidence of safety endpoints, in patients exposed to Duavee compared to estrogen + progestin (E+P) combination hormone replacement therapy (HRT) in the United States. This protocol describes a non-interventional study (NIS) designated as a Post-Authorization Safety Study (PASS) that will be conducted in the US in order to fulfill a post-authorization commitment to the European Medicines Agency (EMA).
• Study status:
  Finalised

Research institutions and networks

Institutions

HealthCore

Study timelines

Date when funding contract was signed

Planned: 23/10/2014

Actual: 23/10/2014

Study start date

Planned: 01/11/2015

Actual: 01/05/2014

Data analysis start date

Actual: 01/11/2015

Date of final study report

Planned: 31/03/2021

Actual: 31/03/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer, Inc

Study protocol

Initial protocol

B2311060_Duavive US PASS FINAL Protocol CHMP ENDORSED 22OCT2015

Updated protocol

B2311060_Duavive US PASS FINAL Protocol CHMP ENDORSED 22OCT2015 AMENDED 21AUG2019_FINAL_clean (w-approval record)

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)