Regulatory Post Marketing Surveillance Study in Korea
- Registration Number
- NCT01788722
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3223
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
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Exclusion Criteria
- All contraindications according to the local marketing authorization have to be considered.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Dienogest (Visanne, BAY86-5258) -
- Primary Outcome Measures
Name Time Method Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability up to 1 year
- Secondary Outcome Measures
Name Time Method 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