EndometriosisENVISIOeNNCT02425462
To Evaluate Effectiveness of Visanne in Improving Quality of Life in Asian Women With Endometriosis
An observational study of Endometriosis, run by Bayer at 6 sites in 6 countries.
Trial summary
This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 870 patients with endometriosis for whom a decision has been made by the physician to treat with dienogest according to local health authority approved label. 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?
- Dienogest (Visanne, BAY86-5258)
- Type of treatment
- Pill or oral medicine
- How many people
- 895 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 28 Apr 2015to 14 Dec 2018
- 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: Asian patients at least 18 years of age with Clinical or surgical diagnosis of endometriosis, and patients with endometriosis associated pelvic pain
Who may be able to join
- Asian Female patients at least 18 years of age
- Clinical or surgical diagnosis of endometriosis (depending on local approved indication) : Clinical diagnosis by suggestive symptoms and positive finding in imaging study (Chocolate cyst)
- Patients with Endometriosis associated pelvic pain
- Decision taken by the physician to newly prescribe Visanne®
- Availability of a signed informed consent
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Patients for whom any of contraindication listed in the local summary of product characteristics (SPC) apply.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: EffectiveNess of VISanne® in Improving Quality of Life in asIan wOmen With eNdometriosis
This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 870 patients with endometriosis for whom a decision has been made by the physician to treat with dienogest according to local health authority approved label. It is the aim of this observational cohort study to further characterize the effectiveness of dienogest in improving quality of life and long-term safety in routine clinical practice setting. Endometriosis is chronic and progressive disease and there is unmet need for long-term treatment. Visanne® with proven efficacy and safety, can be good option for long-term treatment, however, experience with Visanne® beyond 15 month is limited. And long-term up to 24 months data on effectiveness and safety of Visanne would support the long-term treatment strategy for Endometriosis management in the clinical practice.
- Conditions
- Endometriosis
- Being tested
- Dienogest (Visanne, BAY86-5258)
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dienogest (Visanne, BAY86-5258)Drug
Dienogest 2mg daily Oral dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Asian patients at least 18 years of age with clinical or surgical diagnosis of endometriosis, and patients with endometriosis associated pelvic pain. Receives: Drug: Dienogest (Visanne, BAY86-5258) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change from baseline to 6 months of treatment in pain-related Quality of Life measured by EHP-30.
Measured: Baseline and at 6 months
The mean change from baseline to 24 months of treatment in pain-related Quality of Life measured by EHP-30 for patients who continue to take Visanne up to 24 months.
Measured: Baseline and to 24 months
Secondary outcomes (11)
Mean change from baseline to 6 months and baseline to 24 months of treatment in other domain of Quality of life measured by EHP-30
Other domain includes control and powerlessness, emotional wellbeing, social support, self-image as well as modular domain including work life, sexual intercourse, relationship with children, treatment and concern on infertility
Measured: Baseline and 6 months,Baseline to 24 months
Mean change of Endometriosis-associated pelvic pain (EAPP) from baseline in patients with endometriosis either surgically or clinically diagnosed.
Measured: Baseline and 6 months, Baseline and 12 months, Baseline and 24 months
Patient and physician's satisfaction score on Visanne® treatment
The subject and physician will be asked to choose any of following; very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied.
Measured: At 6 months, 12 months, 24 months
Proportion of subjects who continue treatment with Visanne®
Measured: At 6 months, 12 months, 24 months
Reasons for stopping of treatment with Visanne®
Measured: At 6 months, 12 months, 24 months
Proportion of patients with amenorrhea, intermenstrual bleeding/spotting or irregular bleeding while treatment with Visanne®
Measured: At 1 month, 3 months, 6 months, 12 months, and 24 months
Proportion of patients who experienced pain recurrence in patients taking Visanne up to 24 months
Measured: Up to 24 months
Time point for first pain recurrence after stopping taking Visanne and before to start any treatment.
Pain recurrence is defined as severity of pain graded > 4 on the 10-point NRS
Measured: Up to 24 months
Proportion of patients who underwent repeated surgery in patients taking Visanne up to 24 months
Measured: Up to 24 months
Proportion of patients who underwent repeated surgery between stopping Visanne treatment and starting any other treatment than surgery
Measured: Up to 24 months
Patient's assessment of overall symptom development using the Clinical Global Impression (CGI) scale
Measured: At 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study start28 Apr 2015
- Primary completion28 Sep 2018
- Study completion14 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 895 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
- NCT02425462
- Sponsor's protocol ID
- 17444
- Acronym
- ENVISIOeN
- Status last verified
- Sep 2019
- First submitted
- 21 Apr 2015
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Techatraisak K, Hestiantoro A, Ruey S, Banal-Silao MJ, Kim MR, Seong SJ, Thaufik S, Ahlers C, Shin SY, Lee BS. Effectiveness of dienogest in improving quality of life in Asian women with endometriosis (ENVISIOeN): interim results from a prospective cohort study under real-life clinical practice. BMC Womens Health. 2019 May 16;19(1):68. doi: 10.1186/s12905-019-0758-6.
PubMed 31096979Techatraisak K, Hestiantoro A, Soon R, Banal-Silao MJ, Kim MR, Seong SJ, Hidayat ST, Cai L, Shin S, Lee BS. Impact of Long-Term Dienogest Therapy on Quality of Life in Asian Women with Endometriosis: the Prospective Non-Interventional Study ENVISIOeN. Reprod Sci. 2022 Apr;29(4):1157-1169. doi: 10.1007/s43032-021-00787-w. Epub 2022 Feb 2.
PubMed 35112299
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EffectiveNess of VISanne® in Improving Quality of Life in asIan wOmen With eNdometriosis
- ClinicalTrials.gov ID
- NCT02425462
- Acronym / sponsor ID
- ENVISIOeN / 17444
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 895 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2015 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 14 Dec 2018 (actual)
- First posted
- 24 Apr 2015 (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.
This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 870 patients with endometriosis for whom a decision has been made by the physician to treat with dienogest according to local health authority approved label. It is the aim of this observational cohort study to further characterize the effectiveness of dienogest in improving quality of life and long-term safety in routine clinical practice setting. Endometriosis is chronic and progressive disease and there is unmet need for long-term treatment. Visanne® with proven efficacy and safety, can be good option for long-term treatment, however, experience with Visanne® beyond 15 month is limited. And long-term up to 24 months data on effectiveness and safety of Visanne would support the long-term treatment strategy for Endometriosis management in the clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Dienogest (Visanne, BAY86-5258)Asian patients at least 18 years of age with clinical or surgical diagnosis of endometriosis, and patients with endometriosis associated pelvic pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asian patients at least 18 years of age with Clinical or surgical diagnosis of endometriosis, and patients with endometriosis associated pelvic pain
Key inclusion criteria (5 listed)
- Asian Female patients at least 18 years of age
- Clinical or surgical diagnosis of endometriosis (depending on local approved indication) : Clinical diagnosis by suggestive symptoms and positive finding in imaging study (Chocolate cyst)
- Patients with Endometriosis associated pelvic pain
- Decision taken by the physician to newly prescribe Visanne®
- Availability of a signed informed consent
Key exclusion criteria (2 listed)
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Patients for whom any of contraindication listed in the local summary of product characteristics (SPC) apply.
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 |
|---|---|---|
| Dienogest (Visanne, BAY86-5258)Dienogest 2mg daily Oral dose | Drug | Cohort 1 |
Primary outcome
The mean change from baseline to 6 months of treatment in pain-related Quality of Life measured by EHP-30.
Time frame: Baseline and at 6 months
The mean change from baseline to 24 months of treatment in pain-related Quality of Life measured by EHP-30 for patients who continue to take Visanne up to 24 months.
Time frame: Baseline and to 24 months
11 secondary outcomes
Mean change from baseline to 6 months and baseline to 24 months of treatment in other domain of Quality of life measured by EHP-30
Time frame: Baseline and 6 months,Baseline to 24 months
Mean change of Endometriosis-associated pelvic pain (EAPP) from baseline in patients with endometriosis either surgically or clinically diagnosed.
Time frame: Baseline and 6 months, Baseline and 12 months, Baseline and 24 months
Patient and physician's satisfaction score on Visanne® treatment
Time frame: At 6 months, 12 months, 24 months
Proportion of subjects who continue treatment with Visanne®
Time frame: At 6 months, 12 months, 24 months
Reasons for stopping of treatment with Visanne®
Time frame: At 6 months, 12 months, 24 months
Proportion of patients with amenorrhea, intermenstrual bleeding/spotting or irregular bleeding while treatment with Visanne®
Time frame: At 1 month, 3 months, 6 months, 12 months, and 24 months
Proportion of patients who experienced pain recurrence in patients taking Visanne up to 24 months
Time frame: Up to 24 months
Time point for first pain recurrence after stopping taking Visanne and before to start any treatment.
Time frame: Up to 24 months
Proportion of patients who underwent repeated surgery in patients taking Visanne up to 24 months
Time frame: Up to 24 months
Proportion of patients who underwent repeated surgery between stopping Visanne treatment and starting any other treatment than surgery
Time frame: Up to 24 months
Patient's assessment of overall symptom development using the Clinical Global Impression (CGI) scale
Time frame: At 6 months, 12 months, 24 months
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 25 Sep 2019.
- Results publication: PubMed 31096979Techatraisak K, Hestiantoro A, Ruey S, Banal-Silao MJ, Kim MR, Seong SJ, Thaufik S, Ahlers C, Shin SY, Lee BS. Effectiveness of dienogest in improving quality of life in Asian women with endometriosis (ENVISIOeN): interim results from a prospective cohort study under real-life clinical practice. BMC Womens Health. 2019 May 16;19(1):68. doi: 10.1186/s12905-019-0758-6.
- Derived from this study: PubMed 35112299Techatraisak K, Hestiantoro A, Soon R, Banal-Silao MJ, Kim MR, Seong SJ, Hidayat ST, Cai L, Shin S, Lee BS. Impact of Long-Term Dienogest Therapy on Quality of Life in Asian Women with Endometriosis: the Prospective Non-Interventional Study ENVISIOeN. Reprod Sci. 2022 Apr;29(4):1157-1169. doi: 10.1007/s43032-021-00787-w. Epub 2022 Feb 2.
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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
6 sites in 6 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 6 sites in 6 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 2 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Indonesia, Malaysia, Philippines, Singapore, South Korea and 1 more country. 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?
The mean change from baseline to 6 months of treatment in pain-related Quality of Life measured by EHP-30. (time frame: Baseline and at 6 months). 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?
On the ClinicalTrials.gov record for NCT02425462, which also lists 2 linked publications.
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 25 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.