NCT01595724

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,006

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Geographic Reach
11 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

May 9, 2012

Last Update Submit

July 9, 2015

Conditions

Endometriosis

Keywords

Non-interventional studyEndometriosis,Quality of life

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • 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

  • Reasons for treatment discontinuation

    after 6 months of treatment

  • Safety variables will be summarized using descriptive statistics based on adverse events collection

    after 6 months of treatment

Study Arms (1)

Group 1

Drug: Visanne (Dienogest, BAY86-5258)

Interventions

Visanne (Dienogest, BAY86-5258)DRUG

Intake of Dienogest 2mg/day to treat Endometriosis according to regular clinical practice.

Group 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Gynecological patients

You may qualify if:

  • 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

You may not qualify if:

  • Contraindications listed in the local summary of product characteristics (SPC) have to be considered.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Many Locations, Belarus

Location

Unknown Facility

Many Locations, Egypt

Location

Unknown Facility

Many Locations, Jordan

Location

Unknown Facility

Many Locations, Kazakhstan

Location

Unknown Facility

Many Locations, Kuwait

Location

Unknown Facility

Many Locations, Lebanon

Location

Unknown Facility

Many Locations, Qatar

Location

Unknown Facility

Many Locations, Russia

Location

Unknown Facility

Many Locations, Saudi Arabia

Location

Unknown Facility

Many Locations, Ukraine

Location

Unknown Facility

Many Locations, United Arab Emirates

Location

MeSH Terms

Conditions

Endometriosis

Interventions

dienogest

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 10, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2014

Study Completion

May 1, 2015

Last Updated

July 10, 2015

Record last verified: 2015-07

Locations

BE(1)UA(1)JO(1)KU(1)EG(1)LE(1)AE(1)SA(1)KA(1)RU(1)QA(1)