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

Contact details

Klaas Heinemann

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of final study report

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

More details on funding

Bayer Schering Pharmaceuticals
Study protocol
Initial protocol

VIPOS_Study Protocol

English (158.25 KB - 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 3 (required)