Use of products containing oestrogens alone and oestrogens in combination with progestogens (not contraceptives) between 2000 and 2014 in France, Germany and the UK

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/32501
• EU PAS number:
  EUPAS32500
• Study ID:
  32501
• Official title and acronym:
  Use of products containing oestrogens alone and oestrogens in combination with progestogens (not contraceptives) between 2000 and 2014 in France, Germany and the UK
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  United Kingdom
• Study description:
  The objective of the study is to estimate the extent of use and the duration of use of products containing oestrogens alone and oestrogens in combination with progestogens, primarily for HRT, between the years 2000-2014 in several European Union Member States, namely the United Kingdom (UK), France (FR) and Germany (DE). It should be noted that it is not possible to identify these products exclusively in the context of HRT but the ATC codes were selected with this consideration in mind and the age distribution of the women in the study suggests that this strategy is generally successful. The study is not restricted to specific age groups since, although the motivation for the study arises from the findings in women treated with HRT, the exposure of women to the same drugs in the context of other indications is also of interest
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 15/05/2015

Actual: 15/05/2015

Study start date

Planned: 15/05/2015

Actual: 15/05/2015

Data analysis start date

Planned: 15/05/2015

Actual: 15/05/2015

Date of final study report

Planned: 07/09/2015

Actual: 07/09/2015

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