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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


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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