Study identification

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

Contact details

Maria Clara Restrepo Mendez

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable