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Visanne Post-approval Observational Study (VIPOS)

This study is currently recruiting participants.
Verified August 2012 by Center for Epidemiology and Health Research, Germany
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Juergen Dinger, MD, PhD, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier:
NCT01266421
First received: December 23, 2010
Last updated: August 15, 2012
Last verified: August 2012
History of Changes
  Purpose

The study assesses safety aspects of Dienogest (DNG) 2mg/day (Visanne) used as endometriosis therapy and of other hormonal treatments for endometriosis.


Condition
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:

U.S. FDA Resources

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

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

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


Estimated Enrollment: 25000
Study Start Date: December 2010
Estimated Study Completion Date: December 2016
Groups/Cohorts
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women using medications for the treatment of endometriosis

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266421

Contacts
Contact: Anita Assmann, MSc +49 30 945 101 30 assmann@zeg-berlin.de
Contact: Klaas Heinemann, PhD, MD, MBA +49 30 945 101 24 k.heinemann@zeg-berlin.de

Locations
Germany
Center for Epidemiology and Health Research Recruiting
Berlin, Germany, 10115
Contact: Anita Assmann, MSc     +49 30 945 101 30     assmann@zeg-berlin.de    
Contact: Klaas Heinemann, PhD, MD, MBA     +49 30 945 101 24     k.heinemann@zeg-berlin.de    
Principal Investigator: Juergen C Dinger, PhD, MD            
Sponsors and Collaborators
Center for Epidemiology and Health Research, Germany
Bayer
Investigators
Principal Investigator: Juergen C Dinger, PhD, MD Center for Epidemiology and Health Research
  More Information

No publications provided

Responsible Party: Juergen Dinger, MD, PhD, Principal Investigator, Center for Epidemiology and Health Research, Germany
ClinicalTrials.gov Identifier: NCT01266421     History of Changes
Other Study ID Numbers: ZEG2010_03
Study First Received: December 23, 2010
Last Updated: August 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013