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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01595724
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : July 10, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.

Condition or disease Intervention/treatment
Endometriosis Drug: Visanne (Dienogest, BAY86-5258)

Study Design
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Study Type : Observational
Actual Enrollment : 3006 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : May 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
Drug Information available for: Dienogest

Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1 Drug: Visanne (Dienogest, BAY86-5258)
Intake of Dienogest 2mg/day to treat Endometriosis according to regular clinical practice.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients, who show an improvement of the EHP-5 items [ Time Frame: after 6 months of treatment ]
  2. Mean changes of EHP-5 items by using scores for pre-defined categories [ Time Frame: after 6 months of treatment ]

Secondary Outcome Measures :
  1. Baseline demographic characteristics and disease status of patients with endometriosis treated with Visanne [ Time Frame: Baseline ]
  2. Patient reported severity of endometriosis related pain [ Time Frame: Baseline and after 6 months of treatment ]
  3. Reasons for treatment discontinuation [ Time Frame: after 6 months of treatment ]
  4. Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: after 6 months of treatment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Gynecological patients
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595724


Locations
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Belarus
Many Locations, Belarus
Egypt
Many Locations, Egypt
Jordan
Many Locations, Jordan
Kazakhstan
Many Locations, Kazakhstan
Kuwait
Many Locations, Kuwait
Lebanon
Many Locations, Lebanon
Qatar
Many Locations, Qatar
Russian Federation
Many Locations, Russian Federation
Saudi Arabia
Many Locations, Saudi Arabia
Ukraine
Many Locations, Ukraine
United Arab Emirates
Many Locations, United Arab Emirates
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01595724    
Other Study ID Numbers: 16108
VS1101 ( Other Identifier: company internal )
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: July 10, 2015
Last Verified: July 2015
Keywords provided by Bayer:
Non-interventional study
Endometriosis,
Quality of life
Additional relevant MeSH terms:
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Endometriosis
Dienogest
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Contraceptives, Oral
Contraceptive Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents