Trial Condition(s):

Endometriosis

To evaluate effectiveness of Visanne in improving quality of life in asian women with Endometriosis (ENVISIOeN)

Bayer Identifier:

17444

ClinicalTrials.gov Identifier:

NCT02425462

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 870 patients with endometriosis for whom a decision has been made by the physician to treat with dienogest according to local health authority approved label. It is the aim of this observational cohort study to further characterize the effectiveness of dienogest in improving quality of life and long-term safety in routine clinical practice setting. Endometriosis is chronic and progressive disease and there is unmet need for long-term treatment. Visanne® with proven efficacy and safety, can be good option for long-term treatment, however, experience with Visanne® beyond 15 month is limited. And long-term up to 24 months data on effectiveness and safety of Visanne would support the long-term treatment strategy for Endometriosis management in the clinical practice.

Inclusion Criteria
- Asian Female patients at least 18 years of age
- Clinical or surgical diagnosis of endometriosis (depending on local approved indication) : Clinical diagnosis by suggestive symptoms and positive finding in imaging study (Chocolate cyst)
- Patients with Endometriosis associated pelvic pain  
- Decision taken by the physician to newly prescribe Visanne®
- Availability of a signed informed consent
Exclusion Criteria
- Patients participating in an investigational program with interventions outside of routine clinical practice 
 - Patients for whom any of contraindication listed in the local summary of product characteristics (SPC) apply.

Trial Summary

Enrollment Goal
895
Trial Dates
black-arrow
Phase
4
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 Loactions, Indonesia

Status
Completed
 
Locations

Investigative Site

Many Loactions, South Korea

Status
Completed
 
Locations

Investigative Site

Many Loactions, Malaysia

Status
Completed
 
Locations

Investigative Site

Many Loactions, Philippines

Status
Completed
 
Locations

Investigative Site

Many Loactions, Thailand

Status
Completed
 
Locations

Investigative Site

Many Loactions, Singapore

Status
Completed
 

Trial Design