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Regulatory Post Marketing Surveillance Study in Korea

NCT01788722 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3223

Last updated 2018-08-02

No results posted yet for this study

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.

Conditions

  • Endometriosis

Interventions

DRUG

Dienogest (Visanne, BAY86-5258)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-19
Primary Completion
2017-08-11
Completion
2017-08-11

Countries

  • South Korea

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01788722 on ClinicalTrials.gov