Regulatory Post Marketing Surveillance Study in Korea

Bayer

Status: Completed

Conditions: Endometriosis

Treatments: Drug: Dienogest (Visanne, BAY86-5258)

Study type: Observational

Funder types: Industry

Identifiers

NCT01788722

VS1310KR (Other Identifier)

16625

Details and patient eligibility

About

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.

Enrollment: 3,223 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

3,223 participants in 1 patient group

Group 1

Treatment:

Drug: Dienogest (Visanne, BAY86-5258)