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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

895 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-28

Study Completion Date

2018-12-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

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

Dienogest (Visanne, BAY86-5258)

Intervention Type DRUG

Dienogest 2mg daily Oral dose

Interventions

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Dienogest (Visanne, BAY86-5258)

Dienogest 2mg daily Oral dose

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No