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Completed

NCT Number: NCT01595724

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

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Belarus

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Visanne (Dienogest, BAY86-5258)

Drug

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

Primary outcomes

  1. Percentage of patients, who show an improvement of the EHP-5 items

    Time frame: after 6 months of treatment

  2. Mean changes of EHP-5 items by using scores for pre-defined categories

    Time frame: after 6 months of treatment

Secondary outcomes

  1. Baseline demographic characteristics and disease status of patients with endometriosis treated with Visanne

    Time frame: Baseline

  2. Patient reported severity of endometriosis related pain

    Time frame: Baseline and after 6 months of treatment

  3. Reasons for treatment discontinuation

    Time frame: after 6 months of treatment

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

    Time frame: after 6 months of treatment

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Acronym: DIVA

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
May 10, 2012
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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