Visanne Post-approval Observational Study (VIPOS)

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

Detailed Description
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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.

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

Conditions
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Endometriosis

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dienogest (DNG)<br>Women using DNG) for the treatment of endometriosis | |
| Other approved endometriosis drugs (OAED)<br>Women using hormonal medications approved for endometriosis treatment in all particiapting countries other than DNG. | |
| Non-approved endometriosis drugs (NAED)<br>Women using hormonal medications not approved for endometriosis treatment in all particiapting countries. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DNG, Anemia, Depression