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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01595724

Acronym

DIVA

Enrollment

3006

Registered

2012-05-10

Start date

2012-05-31

Completion date

2015-05-31

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

Non-interventional study, Endometriosis,, Quality of life

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.

Interventions

DRUGVisanne (Dienogest, BAY86-5258)

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Belarus, Egypt, Jordan, Kazakhstan, Kuwait, Lebanon, Qatar, Russia, Saudi Arabia, Ukraine, United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026