Study identification

PURI

https://redirect.ema.europa.eu/resource/14145

EU PAS number

EUPAS3718

Study ID

14145

Official title and acronym

EMA drug utilisation study of cyproterone-ethinylestradiol products

DARWIN EU® study

No

Study countries

France
Germany
United Kingdom

Study description

To aim of the study is to analyse drug utilisation of cyproterone/ethinylestradiol products in electronic health record databases from the UK, France and Germany. The study period is 2002-2011. The study period was selected in order to have all three databases collecting data as well as completeness of data in each year.For each of the three databases all patients receiving cyproterone/ethinylestradiol during 2002-2011 have been identified. The German database contains the medical records of private specialists, here the data from internists, gynaecologist and dermatologists will be used, while the rest will be excluded. For the two other countries, the databases contain data from General Practitioners.Co-prescribing of any of the 2nd, 3rd, and 4th generation CHC (Combined Hormonal Contraceptives) as well as isotretinoin will be investigated.Co-prescribing is defined as any prescription done within 30 days before and after a prescription of cyproterone/ethinylestradiol. The prescribing has to be done by the same physician/General Practitioner practice.The results will be presented as percentages of the study populations of cyproterone/ethinylestradiol users.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Kristian Svendsen

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:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable