Study identification

PURI

https://redirect.ema.europa.eu/resource/31117

EU PAS number

EUPAS8412

Study ID

31117

Official title and acronym

Drug utilization study of cyproterone/ethinylestradiol (Diane®-35 and generics) in the Netherlands, UK and Italy

DARWIN EU® study

No

Study countries

Italy
Netherlands
Spain

Study description

The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics, previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne treatment and (concomitant) use of hormonal contraceptives identified in Healthcare Databases in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).

Study status

Finalised
Research institution and networks

Institutions

Italy HIS: The Health Search institute

Networks

PHARMO: Database Network Netherlands

Contact details

CTP Team / Ref: "ENCePP"/ Bayer Pharma AG Bayer HealthCare AG

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Bayer
Study protocol
Initial protocol

17660_Study Protocol DUS Diane_2014-09-12

English (523.32 KB - PDF)View document
Updated protocol

17660_02_Protocol_V7.0_2017_extension study

English (3.21 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 1 (imposed as condition of marketing authorisation)