Association between exposure to esomeprazole/omeprazole and risk of sexual dysfunction in men

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000242
• EU PAS number:
  EUPAS1000000242
• Study ID:
  1000000242
• Official title and acronym:
  Association between exposure to esomeprazole/omeprazole and risk of sexual dysfunction in men
• DARWIN EU® study:
  No
• Study countries:
  Germany

  United Kingdom
• Study description:
  A cohort study which will investigate a potentially increased risk of sexual dysfunction (SD) among male patients prescribed esomeprazole/omeprazole when compared to: (a) being prescribed alternative treatments from the same drug class (i.e., other proton pump inhibitors, PPIs); (b) being prescribed alternative treatments from another drug class (i.e., histamine type 2 receptor antagonists (H2RAs)); and (c) not being prescribed PPIs or H2RAs despite indications for them (non-initiators).
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 03/03/2024

Actual: 10/04/2024

Study start date

Planned: 22/03/2024

Actual: 26/04/2024

Date of final study report

Planned: 15/08/2024

Actual: 30/08/2024

Study protocol

Updated protocol

FINAL_study_protocol_Esomeprazole and sexual dysfunction_v3.2_FOR PUBLICATION.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable