check_circleStudy Completed
Endometriosis
Bayer Identifier:
16108
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Daily practice treatment and Influence of Visanne on the patient assessment of quality of life
Trial purpose
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.
Key Participants Requirements
Sex
FemaleAge
18 - N/ATrial summary
Enrollment Goal
3006Trial Dates
May 2012 - May 2015Phase
N/ACould I Receive a placebo
NoProducts
Visanne (Dienogest, BAY86-5258)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Russia | |
Completed | Many Locations, Ukraine | |
Completed | Many Locations, Belarus | |
Completed | Many Locations, Kazakhstan | |
Completed | Many Locations, Egypt | |
Completed | Many Locations, Kuwait | |
Completed | Many Locations, Saudi Arabia | |
Completed | Many Locations, Jordan | |
Completed | Many Locations, Lebanon | |
Completed | Many Locations, Qatar | |
Completed | Many Locations, United Arab Emirates |
Primary Outcome
- Percentage of patients, who show an improvement of the EHP-5 itemsdate_rangeTime Frame:after 6 months of treatmentenhanced_encryptionNoSafety Issue:
- Mean changes of EHP-5 items by using scores for pre-defined categoriesdate_rangeTime Frame:after 6 months of treatmentenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Baseline demographic characteristics and disease status of patients with endometriosis treated with Visannedate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Patient reported severity of endometriosis related paindate_rangeTime Frame:Baseline and after 6 months of treatmentenhanced_encryptionNoSafety Issue:
- Reasons for treatment discontinuationdate_rangeTime Frame:after 6 months of treatmentenhanced_encryptionNoSafety Issue:
- Safety variables will be summarized using descriptive statistics based on adverse events collectiondate_rangeTime Frame:after 6 months of treatmentenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A