Regulatory Post Marketing Surveillance Study in Korea

Bayer3,223 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,223

Conditions

Endometriosis

Interventions

Dienogest (Visanne, BAY86-5258)DRUG

Patients in daily life clinical practice treatment receiving Visanne (dienogest 2mg) according to indication on the label.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Multiple Locations, South Korea

Outcomes

Primary Outcomes

Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability

Time frame: up to 1 year

Secondary Outcomes

Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study population

Time frame: 6 months and 1 year

Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit).

Time frame: 6 months and 1 year

Data from ClinicalTrials.gov

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