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

NCT02425462 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 895

Last updated 2019-09-25

No results posted yet for this study

Summary

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.

Conditions

  • Endometriosis

Interventions

DRUG

Dienogest (Visanne, BAY86-5258)

Dienogest 2mg daily Oral dose

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-28
Primary Completion
2018-09-28
Completion
2018-12-14

Countries

  • Indonesia
  • Malaysia
  • Philippines
  • Singapore
  • South Korea
  • Thailand

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 NCT02425462 on ClinicalTrials.gov