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

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Bayer

Status

Completed

Conditions

Endometriosis

Treatments

Drug: Visanne (Dienogest, BAY86-5258)

Study type

Observational

Funder types

Industry

Identifiers

NCT01595724
VS1101 (Other Identifier)
16108

Details and patient eligibility

About

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.

Enrollment

3,006 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

3,006 participants in 1 patient group

Group 1
Treatment:
Drug: Visanne (Dienogest, BAY86-5258)

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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