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Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that lines the uterus starts to grow outside of the uterus. 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 and requires long-term treatment to control the symptoms.
For some women with endometriosis, symptoms can return after they stop treatment. Or, they may not be able to tolerate the current long-term treatment options.
In this study, researchers will find out more about the safety of long-term treatment with dienogest in a large number of Chinese participants. This study will enroll patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis. All of the participants will take dienogest based on their doctor's instructions. They will then visit their doctor's office 3 times over 6 months. During these visits, their doctors will ask them if they have any health problems and about their quality of life. Their doctors will also do tests to measure the pain caused by their endometriosis and any other symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visanne treatment | Patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis, who have been prescribed Visanne |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dienogest (Visanne,BAY86_5258) | Drug | 2 mg (once a day), oral, tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The absolute number of AEs reported with Visanne treatment | AE: Adverse Event | From baseline up to 6 months |
| The absolute number of ADRs reported with Visanne treatment | ADR: Adverse drug reaction | From baseline up to 6 months |
| The proportion of AEs reported with Visanne treatment | Proportion of each AE will be calculated as number of patients with at least one event divided by the total number of patients. | From baseline up to 6 months |
| The proportion of ADRs reported with Visanne treatment | Proportion of each ADR will be calculated as number of patients with at least one event divided by the total number of patients. | From baseline up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Numeric Rating Scale (NRS) score of Endometriosis Associated Pelvic Pain (EAPP) of Visanne treatment | NRS: 0-10 integers."absence of pain" corresponds to the value of "0" and unbearable pain corresponding to the value of "10". | From baseline up to 1,3,6 months |
| Endometriosis Health Profile-5 (EHP-5) score changes with Visanne treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese patients from post-menarche to menopause diagnosed with endometriosis, either surgically or clinically, and prescribed with Visanne by a physician according to China's health authority approved label.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | China |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C023635 | dienogest |
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EHP-5 contains 11 questions (items): five items including pain, control and powerlessness, emotional well-being, lack of social support, self image from the core questionnaire and six items from the modular questionnaire that may not be applicable to every woman with endometriosis including work, intercourse, and worries about infertility, treatment, and relationship with children and medical professionals. Each item is rated on a four-point scale (never = 0, rarely = 1, sometimes = 2, often = 3, always = 4 and not relevant if not applicable). |
| At baseline and 6 months. |
| Patient and physician's satisfaction score on VisanneĀ® treatment | Satisfaction will be assessed in 5 scales (very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied) | At 3 and 6 months |
| Changes in Clinical Global Impression (CGI) scale scores of overall symptom development | CGI scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse | At 3 and 6 months |
| Changes in Patient Global Impression (PGI-C) scale scores of overall symptom development | PGI-C scale: very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse | At 3 and 6 months |
| Reasons for discontinuation of using Visanne | Discontinuation reasons identification:
| From baseline up to 6 months |
| The proportion of participant with amenorrhea, infrequent bleeding, frequent bleeding irregular bleeding, prolonged bleeding upon treatment with Visanne | At baseline, 1, 3, and 6 months |
| D000091662 | Genital Diseases |