International Active Surveillance Study of Women Taking Dienogest for Endometriosis: Visanne Post-approval Observational Study (VIPOS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33207
• EU PAS number:
  EUPAS1613
• Study ID:
  33207
• Official title and acronym:
  International Active Surveillance Study of Women Taking Dienogest for Endometriosis: Visanne Post-approval Observational Study (VIPOS)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Hungary

  Poland

  Russian Federation

  Switzerland

  Ukraine
• Study description:
  Endometriosis is a common, chronic, gynecological disease characterized by pain and imparied fertility. The proportion of premenopausal women with endometriosis is approximately 10%. Symptoms seem to repond to decreased circulating estrogen and the mainstay of medical treatment is hormonal induced anovulation and a reduction in endogenous estrogen production.Dienogest (DNG) is a progestogen that is highly selective for progesterone receptors. It has been available as part of a combined oral contraceptive containing 2mg DNG and 30mcg of ethinylestradiol in Germany since 1995. As a monotherapy for endometriosis treatment DNG 2mg/day has been available in Japan since 2008 where it has been found to be a reliable and effective treatment for symptoms associated with endometriosis.Two well-known class effects of progestogens are the induction of bleeding disturbances and mood disturbances. Bleeding disturbances are a common symptom of endometriosis and it is not known what influence DNG will have on bleeding disturbances associated with endometriosis. In addition, women who suffer from endometriosis are at high risk of developing depression. The complexities and potential interaction between depresion, endometriosis and progestogens make it difficult to differentiate whether a woman's symptoms are causally associated with progestin use. A population-based post-authorization safety study (PASS) is needed to assess the potential influence of DNG on mood disturbances in endometriosis patients.The VIPOS study will have a similar study design to the EURAS/INAS study design. This has been shown to be a suitable study design for monitoring the safety of hormonal preparations under real-life user conditions.
• Study status:
  Finalised

Research institutions and networks

Institutions

Berlin Center for Epidemiology & Health Research, ZEG Berlin

Germany

Study timelines

Date when funding contract was signed

Planned: 01/10/2010

Actual: 03/12/2010

Study start date

Planned: 01/12/2010

Actual: 07/12/2010

Data analysis start date

Actual: 21/01/2019

Date of final study report

Planned: 31/03/2019

Actual: 04/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer Schering Pharmaceuticals

Study protocol

Initial protocol

VIPOS_Study Protocol

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)