A Study to Learn More About How Safe Dienogest is and How Well it Works Under Real World Conditions in Indian Women With Endometriosis

Study Overview
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Brief Summary
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Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that normally covers the inside of the womb grows outside the womb. This can cause pain during their periods or during sex, and constant pain in the pelvis. Endometriosis can decrease a woman's quality of life. It also requires long-term treatment to control the symptoms. The study drug, dienogest, has already been approved as a treatment for endometriosis associated pelvic pain. Sometimes, researchers continue studying a treatment after it has been approved to learn more about its safety. In this study, the researchers want to learn more about any medical problems the patients have while taking dienogest. To answer this question, the researchers will collect the medical problems the patients have after taking dienogest and that may or may not be related to dienogest. These medical problems are also known as adverse events. They will also collect information about the endometriosis associated pelvic pain. The pain measured with a standard rating scale called EAPP (endometriosis-associated pelvic pain) before treatment start and after 6 months of treatment will be compared. The trial will include women with endometriosis associated pelvic pain whose doctors have decided to start treating them with dienogest. It will include about 160 women in India who are at least 18 years old. All of the patients will take dienogest based on their doctor's instructions. They will then visit their study site 3 times over 6 months. At these visits, their doctors will ask them questions about how they are feeling and what medications they are taking. The doctors will do tests to measure the pain caused by the patients' endometriosis and any other symptoms. The doctors will also do physical examinations and check the patients' overall health.

Official Title
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Phase IV Study to Assess the Safety and Effectiveness of Dienogest (Visanne®) Amongst Indian Women With Endometriosis, in Real-world Clinical Practice: the VISAGE Study

Conditions
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Endometriosis Associated Pelvic Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients in India at least 18 years of age Clinical or surgical diagnosis of endometriosis: Clinical diagnosis by suggestive symptoms and positive finding in imaging study (Chocolate cyst) Patients diagnosed with endometriosis associated pelvic pain who have not been previously treated with Dienogest Decision to initiate treatment with Dienogest was made as per investigator's routine treatment practice Signed informed consent Exclusion Criteria: Participation in an investigational program with interventions outside of routine clinical practice Contra-indications according to the local summary of product characteristics (SPC)

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 |
| --- | --- |
| Dienogest<br>Patients with endometriosis who have been prescribed with Dienogest. | Drug: Dienogest (BAY86-5258, Visanne)<br>* Following the physicians' decision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events that occur during treatment with Dienogest | Will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in endometriosis associated pelvic pain | Measured by Numerical Rating Scale (NRS) on an 0-10 EAPP (Endometriosis Associated Pelvic Pain) NRS with absence of pain corresponding to the value 0 and unbearable pain corresponding to the value 10. | 6 months |