Daily Practice Treatment and Influence of Visanne on the... | NCT01595724

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

NCT01595724

Sponsor

Bayer

Status

Completed

Last Update Posted

Jul 10, 2015Estimated

Enrollment

3,006Actual

Phase

Not provided

Conditions

Endometriosis

Interventions

Visanne (Dienogest, BAY86-5258)

Countries

Belarus
Egypt
Jordan
Kazakhstan
Kuwait
Lebanon
Qatar
Russia
Saudi Arabia
Ukraine
United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
VS1101	Other Identifier	company internal

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jul 2014Actual

Completion Date

May 2015Actual

First Submitted Date

May 9, 2012

First Submission Date that Met QC Criteria

May 9, 2012

First Posted Date

May 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2015

Last Update Posted Date

Jul 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,006Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Visanne (Dienogest, BAY86-5258)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Visanne (Dienogest, BAY86-5258)	Drug	Intake of Dienogest 2mg/day to treat Endometriosis according to regular clinical practice.	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients, who show an improvement of the EHP-5 items		after 6 months of treatment
Mean changes of EHP-5 items by using scores for pre-defined categories		after 6 months of treatment

Secondary Outcomes

Measure	Description	Time Frame
Baseline demographic characteristics and disease status of patients with endometriosis treated with Visanne		Baseline
Patient reported severity of endometriosis related pain		Baseline and after 6 months of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Gynecological patients

Sampling Method

Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C023635	dienogest

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Many Locations			Belarus