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

September 24, 2019 updated by: Bayer

EffectiveNess of VISanne® in Improving Quality of Life in asIan wOmen With eNdometriosis

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

895

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 2mg daily Oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mean change from baseline to 6 months of treatment in pain-related Quality of Life measured by EHP-30.
Time Frame: Baseline and at 6 months
Baseline and at 6 months
The mean change from baseline to 24 months of treatment in pain-related Quality of Life measured by EHP-30 for patients who continue to take Visanne up to 24 months.
Time Frame: Baseline and to 24 months
Baseline and to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline to 6 months and baseline to 24 months of treatment in other domain of Quality of life measured by EHP-30
Time Frame: Baseline and 6 months,Baseline to 24 months
Other domain includes control and powerlessness, emotional wellbeing, social support, self-image as well as modular domain including work life, sexual intercourse, relationship with children, treatment and concern on infertility
Baseline and 6 months,Baseline to 24 months
Mean change of Endometriosis-associated pelvic pain (EAPP) from baseline in patients with endometriosis either surgically or clinically diagnosed.
Time Frame: Baseline and 6 months, Baseline and 12 months, Baseline and 24 months
Baseline and 6 months, Baseline and 12 months, Baseline and 24 months
Patient and physician's satisfaction score on Visanne® treatment
Time Frame: At 6 months, 12 months, 24 months
The subject and physician will be asked to choose any of following; very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied.
At 6 months, 12 months, 24 months
Proportion of subjects who continue treatment with Visanne®
Time Frame: At 6 months, 12 months, 24 months
At 6 months, 12 months, 24 months
Reasons for stopping of treatment with Visanne®
Time Frame: At 6 months, 12 months, 24 months
At 6 months, 12 months, 24 months
Proportion of patients with amenorrhea, intermenstrual bleeding/spotting or irregular bleeding while treatment with Visanne®
Time Frame: At 1 month, 3 months, 6 months, 12 months, and 24 months
At 1 month, 3 months, 6 months, 12 months, and 24 months
Proportion of patients who experienced pain recurrence in patients taking Visanne up to 24 months
Time Frame: Up to 24 months
Up to 24 months
Time point for first pain recurrence after stopping taking Visanne and before to start any treatment.
Time Frame: Up to 24 months
Pain recurrence is defined as severity of pain graded > 4 on the 10-point NRS
Up to 24 months
Proportion of patients who underwent repeated surgery in patients taking Visanne up to 24 months
Time Frame: Up to 24 months
Up to 24 months
Proportion of patients who underwent repeated surgery between stopping Visanne treatment and starting any other treatment than surgery
Time Frame: Up to 24 months
Up to 24 months
Patient's assessment of overall symptom development using the Clinical Global Impression (CGI) scale
Time Frame: At 6 months, 12 months, 24 months
At 6 months, 12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2015

Primary Completion (Actual)

September 28, 2018

Study Completion (Actual)

December 14, 2018

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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