To Evaluate Effectiveness of Visanne in Improving Quality of Life in Asian Women With Endometriosis (ENVISIOeN)

Bayer

Status: Completed

Conditions: Endometriosis

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02425462

17444

Details and patient eligibility

About

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.

Enrollment: 895 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

895 participants in 1 patient group

Cohort 1

Description:

Asian patients at least 18 years of age with clinical or surgical diagnosis of endometriosis, and patients with endometriosis associated pelvic pain.

Treatment:

Drug: Dienogest (Visanne, BAY86-5258)