Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28239
• EU PAS number:
  EUPAS9312
• Study ID:
  28239
• Official title and acronym:
  Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Czechia

  France

  Netherlands

  Spain
• Study status:
  Finalised

Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Multiple centres: 5 centres are involved in the study

Contact details

Elizabeth Andrews

Study contact

[e-mail]

Elizabeth Andrews

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 18/08/2014

Actual: 18/08/2014

Data collection

Planned: 25/05/2015

Actual: 26/06/2015

Date of final study report

Planned: 30/06/2016

Actual: 15/08/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer Pharm

Study protocol

Initial protocol

Diane-35 protocol 20 April 2015

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)