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Visanne Post-approval Observational Study (VIPOS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany Identifier:
First received: December 23, 2010
Last updated: November 2, 2016
Last verified: November 2016
The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Active Surveillance Study of Medication Used for the Treatment of Endometriosis: Visanne Post-approval Observational Study

Resource links provided by NLM:

Further study details as provided by Center for Epidemiology and Health Research, Germany:

Primary Outcome Measures:
  • Anemia [ Time Frame: Within 6 years ]
    Medical intervention for anemia induced by cyclical bleeding disturbances (anemia)

  • Depression [ Time Frame: Within 6 years ]
    First time occurence of clinically relevant depression, or worsening of existing depression

Enrollment: 28400
Study Start Date: December 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Dienogest (DNG)
Women using DNG for the treatment of endometriosis
Other medications
Women using hormonal medications other than DNG for the treatment of endometriosis

Detailed Description:

Endometriosis is a common, chronic, gynecological disease characterized by pain and impaired fertility. It causes chronic inflammation, ovarian cyst formation, fibrosis and adhesions. Symptoms seem to respond to decreased circulating estrogen. The mainstay of medical treatment is hormonal induced anovulation and a reduction in endogenous estrogen production.

Medications for endometriosis such as Danazol and GnRH agonists have clinically relevant side-effects limiting treatment duration with these medications to 6-12 months.

Dienogest (DNG) is a 19-nortestosterone derivative progestogen. DNG 2mg/day is a reliable and effective treatment for dysmenorrhea, premenstrual pain, dyspareunia and diffuse pelvic pain associated with endometriosis.

Two important class effects of progestogens are the induction of bleeding disturbances and their influence on mood disturbance. It is not known what influence DNG will have on bleeding disturbances associated with endometriosis, particularly over a longer time frame.

In addition, women who suffer from endometriosis are at high risk of developing depressive symptoms. It is difficult to differentiate if depressive symptoms are causally associated with progestogen use or sequela of the disease process.

This study investigates the safety of DNG for endometriosis with regard to medical interventions for anemia and worsening of depressive symptoms associated with the disease. It is a prospective, controlled, non-interventional cohort study with two cohorts: users of DNG and users of other medications for the treatment of endometriosis. The study will be implemented in several European countries.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women using medications for the treatment of endometriosis

Inclusion Criteria:

  • Women using a newly prescribed regimen for endometriosis (first-time users or switchers)
  • Women who are willing to participate in this long-term follow-up study

Exclusion Criteria:

  • Women who are not cooperative/available for follow-up
  • Women with a language barrier
  Contacts and Locations
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Please refer to this study by its identifier: NCT01266421

Center for Epidemiology and Health Research
Berlin, Germany, 10115
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Principal Investigator: Klaas Heinemann, PhD, MD, MBA Center for Epidemiology and Health Research
  More Information

Responsible Party: Klaas Heinemann, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany Identifier: NCT01266421     History of Changes
Other Study ID Numbers: ZEG2010_03
Study First Received: December 23, 2010
Last Updated: November 2, 2016

Keywords provided by Center for Epidemiology and Health Research, Germany:

Additional relevant MeSH terms:
Genital Diseases, Female processed this record on April 27, 2017