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

Endometriosis Clinical Trial

— DIVA  

Official title:

Study to Characterize Patients Treated With Visanne for Their Endometriosis Under Real-life Practice Conditions and Evaluate Their Quality of Life at Baseline and After 6 Months of Treatment With Visanne.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595724
• Other study ID #: 16108
• Secondary ID: VS1101
• Status: Completed
• Phase: N/A
• First received: May 9, 2012
• Last updated: July 9, 2015
• Start date: May 2012
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belarus: Ministry of HealthKazakhstan: Ethical Commission, Ministry of Public Health, National Center for Expertise of Drugs, Medical Products and EquipmentUkraine: Ethics Committee, Ministry of Health, State Pharmacological CenterRussia: Ethics Committee, FSI Scientific Center of Expertise of Medical Application, Ministry of Health and Social Development of the Russian Federation
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3006
• Est. completion date: May 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Visanne (Dienogest, BAY86-5258)
Intake of Dienogest 2mg/day to treat Endometriosis according to regular clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Belarus,  Egypt,  Jordan,  Kazakhstan,  Kuwait,  Lebanon,  Qatar,  Russian Federation,  Saudi Arabia,  Ukraine,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients, who show an improvement of the EHP-5 items		after 6 months of treatment	No
Primary	Mean changes of EHP-5 items by using scores for pre-defined categories		after 6 months of treatment	No
Secondary	Baseline demographic characteristics and disease status of patients with endometriosis treated with Visanne		Baseline	No
Secondary	Patient reported severity of endometriosis related pain		Baseline and after 6 months of treatment	No
Secondary	Reasons for treatment discontinuation		after 6 months of treatment	No
Secondary	Safety variables will be summarized using descriptive statistics based on adverse events collection		after 6 months of treatment	Yes

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