Endometriosis
Conditions
Brief summary
The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term follow-up visit after about 1 year of treatment under daily practice treatment conditions in Korean women and to obtain data on drug utilization on treatment for endometriosis.
Interventions
Patients in daily life clinical practice treatment receiving Visanne (dienogest 2mg) according to indication on the label.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent * Women diagnosed by a physician as having endometriosis * Women who are prescribed Visanne(dienogest 2mg)for the first time during the study period
Exclusion criteria
\- All contraindications according to the local marketing authorization have to be considered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability | up to 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study population | 6 months and 1 year |
| Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit). | 6 months and 1 year |
Countries
South Korea
Outcome results
None listed