To Evaluate Effectiveness of Visanne in Improving Quality of Life in Asian Women With Endometriosis

Study Overview
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Brief Summary
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This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 870 patients with endometriosis for whom a decision has been made by the physician to treat with dienogest according to local health authority approved label. It is the aim of this observational cohort study to further characterize the effectiveness of dienogest in improving quality of life and long-term safety in routine clinical practice setting. Endometriosis is chronic and progressive disease and there is unmet need for long-term treatment. Visanne® with proven efficacy and safety, can be good option for long-term treatment, however, experience with Visanne® beyond 15 month is limited. And long-term up to 24 months data on effectiveness and safety of Visanne would support the long-term treatment strategy for Endometriosis management in the clinical practice.

Official Title
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EffectiveNess of VISanne® in Improving Quality of Life in asIan wOmen With eNdometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Dienogest (Visanne, BAY86-5258)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asian Female patients at least 18 years of age Clinical or surgical diagnosis of endometriosis (depending on local approved indication) : Clinical diagnosis by suggestive symptoms and positive finding in imaging study (Chocolate cyst) Patients with Endometriosis associated pelvic pain Decision taken by the physician to newly prescribe Visanne® Availability of a signed informed consent Exclusion Criteria: Patients participating in an investigational program with interventions outside of routine clinical practice Patients for whom any of contraindication listed in the local summary of product characteristics (SPC) apply.

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| Cohort 1<br>Asian patients at least 18 years of age with clinical or surgical diagnosis of endometriosis, and patients with endometriosis associated pelvic pain. | Drug: Dienogest (Visanne, BAY86-5258)<br>* Dienogest 2mg daily Oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change from baseline to 6 months of treatment in pain-related Quality of Life measured by EHP-30. |  | Baseline and at 6 months | 
| The mean change from baseline to 24 months of treatment in pain-related Quality of Life measured by EHP-30 for patients who continue to take Visanne up to 24 months. |  | Baseline and to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to 6 months and baseline to 24 months of treatment in other domain of Quality of life measured by EHP-30 | Other domain includes control and powerlessness, emotional wellbeing, social support, self-image as well as modular domain including work life, sexual intercourse, relationship with children, treatment and concern on infertility | Baseline and 6 months,Baseline to 24 months | 
| Mean change of Endometriosis-associated pelvic pain (EAPP) from baseline in patients with endometriosis either surgically or clinically diagnosed. |  | Baseline and 6 months, Baseline and 12 months, Baseline and 24 months | 
| Patient and physician's satisfaction score on Visanne® treatment | The subject and physician will be asked to choose any of following; very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied. | At 6 months, 12 months, 24 months | 
| Proportion of subjects who continue treatment with Visanne® |  | At 6 months, 12 months, 24 months | 
| Reasons for stopping of treatment with Visanne® |  | At 6 months, 12 months, 24 months | 
| Proportion of patients with amenorrhea, intermenstrual bleeding/spotting or irregular bleeding while treatment with Visanne® |  | At 1 month, 3 months, 6 months, 12 months, and 24 months | 
| Proportion of patients who experienced pain recurrence in patients taking Visanne up to 24 months |  | Up to 24 months | 
| Time point for first pain recurrence after stopping taking Visanne and before to start any treatment. | Pain recurrence is defined as severity of pain graded > 4 on the 10-point NRS | Up to 24 months | 
| Proportion of patients who underwent repeated surgery in patients taking Visanne up to 24 months |  | Up to 24 months | 
| Proportion of patients who underwent repeated surgery between stopping Visanne treatment and starting any other treatment than surgery |  | Up to 24 months | 
| Patient's assessment of overall symptom development using the Clinical Global Impression (CGI) scale |  | At 6 months, 12 months, 24 months |