EndometriosisDIVANCT01595724
Daily Practice Treatment and Influence of Visanne on the Patient Assessment of Quality of Life
An observational study of Endometriosis, run by Bayer at 11 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Visanne (Dienogest, BAY86-5258)
- How many people
- 3,006 participants
- Where
- 11 sitesin 11 countries
- Study dates
- May 2012to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Gynecological patients
Who may be able to join
- 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
Who cannot join
- Contraindications listed in the local summary of product characteristics (SPC) have to be considered.
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
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.
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.
- Conditions
- Endometriosis
- Being tested
- Visanne (Dienogest, BAY86-5258)
- Keywords
- Non-interventional study, Endometriosis,, Quality of life
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visanne (Dienogest, BAY86-5258)Drug
Intake of Dienogest 2mg/day to treat Endometriosis according to regular clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Visanne (Dienogest, BAY86-5258) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients, who show an improvement of the EHP-5 items
Measured: after 6 months of treatment
Mean changes of EHP-5 items by using scores for pre-defined categories
Measured: after 6 months of treatment
Secondary outcomes (4)
Baseline demographic characteristics and disease status of patients with endometriosis treated with Visanne
Measured: Baseline
Patient reported severity of endometriosis related pain
Measured: Baseline and after 6 months of treatment
Reasons for treatment discontinuation
Measured: after 6 months of treatment
Safety variables will be summarized using descriptive statistics based on adverse events collection
Measured: after 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,006 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595724
- Sponsor's protocol ID
- 16108
- Other IDs
- VS1101
- Acronym
- DIVA
- Status last verified
- Jul 2015
- First submitted
- 9 May 2012
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01595724
- Acronym / sponsor ID
- DIVA / 16108
- Conditions
- Endometriosis
- Keywords
- Non-interventional study, Endometriosis,, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,006 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Visanne (Dienogest, BAY86-5258) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gynecological patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindications listed in the local summary of product characteristics (SPC) have to be considered.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visanne (Dienogest, BAY86-5258)Intake of Dienogest 2mg/day to treat Endometriosis according to regular clinical practice. | Drug | Group 1 |
Primary outcome
Percentage of patients, who show an improvement of the EHP-5 items
Time frame: after 6 months of treatment
Mean changes of EHP-5 items by using scores for pre-defined categories
Time frame: after 6 months of treatment
4 secondary outcomes
Baseline demographic characteristics and disease status of patients with endometriosis treated with Visanne
Time frame: Baseline
Patient reported severity of endometriosis related pain
Time frame: Baseline and after 6 months of treatment
Reasons for treatment discontinuation
Time frame: after 6 months of treatment
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: after 6 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Bayer at 11 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belarus, Egypt, Jordan, Kazakhstan, Kuwait and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients, who show an improvement of the EHP-5 items (time frame: after 6 months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2015.