Daily Practice Treatment and Influence of Visanne on the Patient Assessment of Quality of Life

NCT ID: NCT01595724

Last Updated: 2015-07-10

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

3006 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-05-31

Brief Summary

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The study aims to collect data on the influence of a treatment with Visanne (Dienogest 2mg/d) on the Endometriosis related quality of life. These data will be collected using a special patient questionnaire (Endometriosis Health Profile 5, EHP-5). The study will also be used to describe the basic disease status and demographic characteristics of patients searching treatment by a gynecologist because of their endometriosis. In addition, the study will give insight into the typical diagnostic measures the physicians in different countries are using in the field of endometriosis.

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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Group 1

Visanne (Dienogest, BAY86-5258)

Intervention Type DRUG

Intake of Dienogest 2mg/day to treat Endometriosis according to regular clinical practice.

Interventions

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Visanne (Dienogest, BAY86-5258)

Intake of Dienogest 2mg/day to treat Endometriosis according to regular clinical practice.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female patients older than 18 years of age
* Clinical or laparoscopic diagnosis of endometriosis
* Having endometriosis related pain as leading symptom
* Decision taken by physician to prescribe Visanne
* Signed Informed Consent Form

Exclusion Criteria

* Contraindications listed in the local summary of product characteristics (SPC) have to be considered.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Belarus

Site Status

Many Locations, , Egypt

Site Status

Many Locations, , Jordan

Site Status

Many Locations, , Kazakhstan

Site Status

Many Locations, , Kuwait

Site Status

Many Locations, , Lebanon

Site Status

Many Locations, , Qatar

Site Status

Many Locations, , Russia

Site Status

Many Locations, , Saudi Arabia

Site Status

Many Locations, , Ukraine

Site Status

Many Locations, , United Arab Emirates

Site Status

Countries

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Belarus Egypt Jordan Kazakhstan Kuwait Lebanon Qatar Russia Saudi Arabia Ukraine United Arab Emirates

Other Identifiers

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VS1101

Identifier Type: OTHER

Identifier Source: secondary_id

16108

Identifier Type: -

Identifier Source: org_study_id

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