- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02425462
To Evaluate Effectiveness of Visanne in Improving Quality of Life in Asian Women With Endometriosis (ENVISIOeN)
September 24, 2019 updated by: Bayer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
895
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Multiple Locations, Indonesia
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Multiple Locations, Korea, Republic of
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Multiple Locations, Malaysia
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Multiple Locations, Philippines
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Multiple Locations, Singapore
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Multiple Locations, Thailand
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Asian patients at least 18 years of age with Clinical or surgical diagnosis of endometriosis, and patients with endometriosis associated pelvic pain
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Cohort 1
Asian patients at least 18 years of age with clinical or surgical diagnosis of endometriosis, and patients with endometriosis associated pelvic pain.
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Dienogest 2mg daily Oral dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Baseline and at 6 months
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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
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Baseline and to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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
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Baseline and 6 months,Baseline to 24 months
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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
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Baseline and 6 months, Baseline and 12 months, Baseline and 24 months
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Patient and physician's satisfaction score on Visanne® treatment
Time Frame: At 6 months, 12 months, 24 months
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The subject and physician will be asked to choose any of following; very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied.
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At 6 months, 12 months, 24 months
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Proportion of subjects who continue treatment with Visanne®
Time Frame: At 6 months, 12 months, 24 months
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At 6 months, 12 months, 24 months
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Reasons for stopping of treatment with Visanne®
Time Frame: At 6 months, 12 months, 24 months
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At 6 months, 12 months, 24 months
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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
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At 1 month, 3 months, 6 months, 12 months, and 24 months
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Proportion of patients who experienced pain recurrence in patients taking Visanne up to 24 months
Time Frame: Up to 24 months
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Up to 24 months
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Time point for first pain recurrence after stopping taking Visanne and before to start any treatment.
Time Frame: Up to 24 months
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Pain recurrence is defined as severity of pain graded > 4 on the 10-point NRS
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Up to 24 months
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Proportion of patients who underwent repeated surgery in patients taking Visanne up to 24 months
Time Frame: Up to 24 months
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Up to 24 months
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Proportion of patients who underwent repeated surgery between stopping Visanne treatment and starting any other treatment than surgery
Time Frame: Up to 24 months
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Up to 24 months
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Patient's assessment of overall symptom development using the Clinical Global Impression (CGI) scale
Time Frame: At 6 months, 12 months, 24 months
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At 6 months, 12 months, 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Techatraisak 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 28, 2015
Primary Completion (Actual)
September 28, 2018
Study Completion (Actual)
December 14, 2018
Study Registration Dates
First Submitted
April 21, 2015
First Submitted That Met QC Criteria
April 21, 2015
First Posted (Estimate)
April 24, 2015
Study Record Updates
Last Update Posted (Actual)
September 25, 2019
Last Update Submitted That Met QC Criteria
September 24, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endometriosis
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Hormonal
- Contraceptive Agents, Male
- Dienogest
Other Study ID Numbers
- 17444
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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