Daily Practice Treatment and Influence of Visanne on the Patient Assessment of Quality of Life - Full Text View

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.

Condition	Intervention
Endometriosis	Drug: Visanne (Dienogest, BAY86-5258)

Study Type:	Observational
Study Design:	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.

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis

Drug Information available for: Dienogest

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Percentage of patients, who show an improvement of the EHP-5 items [ Time Frame: after 6 months of treatment ] [ Designated as safety issue: No ]
Mean changes of EHP-5 items by using scores for pre-defined categories [ Time Frame: after 6 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Baseline demographic characteristics and disease status of patients with endometriosis treated with Visanne [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Patient reported severity of endometriosis related pain [ Time Frame: Baseline and after 6 months of treatment ] [ Designated as safety issue: No ]
Reasons for treatment discontinuation [ Time Frame: after 6 months of treatment ] [ Designated as safety issue: No ]
Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: after 6 months of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	3000
Study Start Date:	May 2012
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595724

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

Belarus
	Recruiting
Many Locations, Belarus
Egypt
	Not yet recruiting
Many Locations, Egypt
Jordan
	Not yet recruiting
Many Locations, Jordan
Kazakhstan
	Recruiting
Many Locations, Kazakhstan
Kuwait
	Not yet recruiting
Many Locations, Kuwait
Lebanon
	Not yet recruiting
Many Locations, Lebanon
Qatar
	Not yet recruiting
Many Locations, Qatar
Russian Federation
	Not yet recruiting
Many Locations, Russian Federation
Saudi Arabia
	Not yet recruiting
Many Locations, Saudi Arabia
Ukraine
	Recruiting
Many Locations, Ukraine
United Arab Emirates
	Not yet recruiting
Many Locations, United Arab Emirates

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT01595724 History of Changes
Other Study ID Numbers:	16108, VS1101
Study First Received:	May 9, 2012
Last Updated:	May 9, 2013
Health Authority:	Belarus: Ministry of Health Kazakhstan: Ethical Commission, Ministry of Public Health, National Center for Expertise of Drugs, Medical Products and Equipment Ukraine: Ethics Committee, Ministry of Health, State Pharmacological Center Russia: Ethics Committee, FSI Scientific Center of Expertise of Medical Application, Ministry of Health and Social Development of the Russian Federation

Keywords provided by Bayer:

Non-interventional study
Endometriosis,
Quality of life

Additional relevant MeSH terms:

Endometriosis
Genital Diseases, Female
Dienogest
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents, Male

ClinicalTrials.gov processed this record on May 19, 2013

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