To Evaluate Effectiveness of Visanne in Improving Quality of Life in Asian Women With Endometriosis

Endometriosis Clinical Trial

— ENVISIOeN  

Official title:

EffectiveNess of VISanne® in Improving Quality of Life in asIan wOmen With eNdometriosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425462
• Other study ID #: 17444
• Status: Completed
• Start date: April 28, 2015
• Est. completion date: December 14, 2018

Study information

• Verified date: September 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 895
• Est. completion date: December 14, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Dienogest (Visanne, BAY86-5258)
Dienogest 2mg daily Oral dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Indonesia,  Korea, Republic of,  Malaysia,  Philippines,  Singapore,  Thailand, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean change from baseline to 6 months of treatment in pain-related Quality of Life measured by EHP-30.		Baseline and at 6 months
Primary	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.		Baseline and to 24 months
Secondary	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	Baseline and 6 months,Baseline to 24 months
Secondary	Mean change of Endometriosis-associated pelvic pain (EAPP) from baseline in patients with endometriosis either surgically or clinically diagnosed.		Baseline and 6 months, Baseline and 12 months, Baseline and 24 months
Secondary	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.	At 6 months, 12 months, 24 months
Secondary	Proportion of subjects who continue treatment with Visanne®		At 6 months, 12 months, 24 months
Secondary	Reasons for stopping of treatment with Visanne®		At 6 months, 12 months, 24 months
Secondary	Proportion of patients with amenorrhea, intermenstrual bleeding/spotting or irregular bleeding while treatment with Visanne®		At 1 month, 3 months, 6 months, 12 months, and 24 months
Secondary	Proportion of patients who experienced pain recurrence in patients taking Visanne up to 24 months		Up to 24 months
Secondary	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	Up to 24 months
Secondary	Proportion of patients who underwent repeated surgery in patients taking Visanne up to 24 months		Up to 24 months
Secondary	Proportion of patients who underwent repeated surgery between stopping Visanne treatment and starting any other treatment than surgery		Up to 24 months
Secondary	Patient's assessment of overall symptom development using the Clinical Global Impression (CGI) scale		At 6 months, 12 months, 24 months

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