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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01595724
First received: May 9, 2012
Last updated: October 20, 2014
Last verified: October 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 ]

Enrollment: 3005
Study Start Date: May 2012
Estimated Study Completion Date: November 2014
Primary Completion Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
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: October 20, 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
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptive Agents, Male
Contraceptives, Oral
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014