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Visanne Post-approval Observational Study (VIPOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01266421
Recruitment Status : Active, not recruiting
First Posted : December 24, 2010
Last Update Posted : August 10, 2018
Information provided by (Responsible Party):
Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany

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

Condition or disease

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.

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Study Type : Observational
Actual Enrollment : 28400 participants
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
Study Start Date : December 2010
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Dienogest (DNG)
Women using DNG for the treatment of endometriosis
Other medications
Women using hormonal medications other than DNG for the treatment of endometriosis

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01266421

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

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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
First Posted: December 24, 2010    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Keywords provided by Klaas Heinemann, MD, PhD, Center for Epidemiology and Health Research, Germany:

Additional relevant MeSH terms:
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Genital Diseases, Female