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

This study is currently recruiting participants.
Verified April 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01595724
First received: May 9, 2012
Last updated: April 10, 2014
Last verified: April 2014
  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:


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
Recruiting
Many Locations, Egypt
Jordan
Recruiting
Many Locations, Jordan
Kazakhstan
Recruiting
Many Locations, Kazakhstan
Kuwait
Recruiting
Many Locations, Kuwait
Lebanon
Recruiting
Many Locations, Lebanon
Qatar
Recruiting
Many Locations, Qatar
Russian Federation
Recruiting
Many Locations, Russian Federation
Saudi Arabia
Recruiting
Many Locations, Saudi Arabia
Ukraine
Recruiting
Many Locations, Ukraine
United Arab Emirates
Recruiting
Many Locations, United Arab Emirates
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01595724     History of Changes
Other Study ID Numbers: 16108, VS1101
Study First Received: May 9, 2012
Last Updated: April 10, 2014
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 April 14, 2014