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

Completed

• Conditions: Endometriosis
• Interventions: Drug: Visanne (Dienogest, BAY86-5258)

• Registration Number: NCT01595724
• Lead Sponsor: Bayer

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Primary Completion: 2014-07
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3006

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

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Exclusion Criteria

• Contraindications listed in the local summary of product characteristics (SPC) have to be considered.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Visanne (Dienogest, BAY86-5258)	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients, who show an improvement of the EHP-5 items	after 6 months of treatment
Mean changes of EHP-5 items by using scores for pre-defined categories	after 6 months of treatment

Secondary Outcome Measures

Name	Time	Method
Baseline demographic characteristics and disease status of patients with endometriosis treated with Visanne	Baseline
Reasons for treatment discontinuation	after 6 months of treatment
Safety variables will be summarized using descriptive statistics based on adverse events collection	after 6 months of treatment
Patient reported severity of endometriosis related pain	Baseline and after 6 months of treatment