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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02425462
• Date of registration: 21/04/2015
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: To Evaluate Effectiveness of Visanne in Improving Quality of Life in Asian Women With Endometriosis ENVISIOeN
• Scientific title: EffectiveNess of VISanne® in Improving Quality of Life in asIan wOmen With eNdometriosis
• Date of first enrolment: April 28, 2015
• Target sample size: 895
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02425462
• Study type: Observational

Countries of recruitment

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

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Endometriosis

Intervention(s)

Drug: Dienogest (Visanne, BAY86-5258)

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

Time point for first pain recurrence after stopping taking Visanne and before to start any treatment. [Time Frame: Up to 24 months]

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]

Patient's assessment of overall symptom development using the Clinical Global Impression (CGI) scale [Time Frame: At 6 months, 12 months, 24 months]

Proportion of patients who experienced pain recurrence in patients taking Visanne up to 24 months [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]

Patient and physician's satisfaction score on Visanne® treatment [Time Frame: At 6 months, 12 months, 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]

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]

Proportion of subjects who continue 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]

Reasons for stopping of treatment with Visanne® [Time Frame: At 6 months, 12 months, 24 months]

Secondary ID(s)

17444

Source(s) of Monetary Support

Please refer to primary and secondary sponsors