Visanne Post-approval Observational Study (VIPOS)

Completed

• Conditions: Endometriosis

• Registration Number: NCT01266421
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-12-07
• Study First Submitted: 2010-12-23
• Study First Submitted QC: 2010-12-23
• Study First Posted: 2010-12-24
• Primary Completion: 2018-10-31
• Study Completion: 2019-01-26
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27840

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Center for Epidemiology and Health Research; 🇩🇪 Berlin, Germany