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.
Study Type
OBSERVATIONAL
Enrollment
895
Dienogest 2mg daily Oral dose
Unnamed facility
Multiple Locations, Indonesia
Unnamed facility
Multiple Locations, Malaysia
Unnamed facility
Multiple Locations, Philippines
Unnamed facility
Multiple Locations, Singapore
Unnamed facility
Multiple Locations, South Korea
Unnamed facility
Multiple Locations, Thailand
The mean change from baseline to 6 months of treatment in pain-related Quality of Life measured by EHP-30.
Time frame: 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.
Time frame: Baseline and to 24 months
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
Time frame: 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.
Time frame: 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.
Time frame: At 6 months, 12 months, 24 months
Proportion of subjects who continue treatment with Visanne®
Time frame: At 6 months, 12 months, 24 months
Reasons for stopping of treatment with Visanne®
Time frame: At 6 months, 12 months, 24 months
Proportion of patients with amenorrhea, intermenstrual bleeding/spotting or irregular bleeding while treatment with Visanne®
Time frame: 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
Time frame: 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
Time frame: Up to 24 months
Proportion of patients who underwent repeated surgery in patients taking Visanne up to 24 months
Time frame: Up to 24 months
Proportion of patients who underwent repeated surgery between stopping Visanne treatment and starting any other treatment than surgery
Time frame: Up to 24 months
Patient's assessment of overall symptom development using the Clinical Global Impression (CGI) scale
Time frame: At 6 months, 12 months, 24 months
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