Visanne Post-approval Observational Study (VIPOS)

July 27, 2020 updated by: Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany

International Active Surveillance Study of Medication Used for the Treatment of Endometriosis: Visanne Post-approval Observational Study

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

27840

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10115
        • Center for Epidemiology and Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women using medications for the treatment of endometriosis

Description

Inclusion Criteria:

  • Women using a newly prescribed regimen for endometriosis (first-time users or switchers or re-starters)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Dienogest (DNG)
Women using DNG) for the treatment of endometriosis
Other approved endometriosis drugs (OAED)
Women using hormonal medications approved for endometriosis treatment in all particiapting countries other than DNG.
Non-approved endometriosis drugs (NAED)
Women using hormonal medications not approved for endometriosis treatment in all particiapting countries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anemia
Time Frame: Within 6 years
Medical intervention for anemia induced by cyclical bleeding disturbances (anemia)
Within 6 years
Depression
Time Frame: Within 6 years
First time occurence of clinically relevant depression, or worsening of existing depression
Within 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Epidemiology and Health Research, Germany

Collaborators

Bayer

Investigators

  • Principal Investigator: Klaas Heinemann, PhD, MD, MBA, Center for Epidemiology and Health Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 7, 2010

Primary Completion (ACTUAL)

October 31, 2018

Study Completion (ACTUAL)

January 26, 2019

Study Registration Dates

First Submitted

December 23, 2010

First Submitted That Met QC Criteria

December 23, 2010

First Posted (ESTIMATE)

December 24, 2010

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZEG2010_03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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