Trial Condition(s):

Endometriosis

Regulatory Post Marketing Surveillance Study in Korea

Bayer Identifier:

16625

ClinicalTrials.gov Identifier:

NCT01788722

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
3223
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, South Korea

Status
Completed
 

Trial Design