check_circleStudy Completed

Endometriosis

Bayer Identifier:

17444

ClinicalTrials.gov Identifier:

NCT02425462

EudraCT Number:

Not Available

EU CT Number:

Not Available
To evaluate effectiveness of Visanne in improving quality of life in asian women with Endometriosis

Trial purpose

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.

Key Participants Requirements

Sex

Female

Age

18 - N/A
  • - 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

  • - 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 summary

Enrollment Goal
895
Trial Dates
April 2015 - December 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Loactions, Indonesia
Completed
Many Loactions, Korea, Republic Of
Completed
Many Loactions, Malaysia
Completed
Many Loactions, Philippines
Completed
Many Loactions, Thailand
Completed
Many Loactions, Singapore

Primary Outcome

  • The mean change from baseline to 6 months of treatment in pain-related Quality of Life measured by EHP-30.
    date_rangeTime Frame:
    Baseline and at 6 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    Baseline and to 24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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
    date_rangeTime Frame:
    Baseline and 6 months,Baseline to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of Endometriosis-associated pelvic pain (EAPP) from baseline in patients with endometriosis either surgically or clinically diagnosed.
    date_rangeTime Frame:
    Baseline and 6 months, Baseline and 12 months, Baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    At 6 months, 12 months, 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of subjects who continue treatment with Visanne®
    date_rangeTime Frame:
    At 6 months, 12 months, 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Reasons for stopping of treatment with Visanne®
    date_rangeTime Frame:
    At 6 months, 12 months, 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of patients with amenorrhea, intermenstrual bleeding/spotting or irregular bleeding while treatment with Visanne®
    date_rangeTime Frame:
    At 1 month, 3 months, 6 months, 12 months, and 24 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Proportion of patients who experienced pain recurrence in patients taking Visanne up to 24 months
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of patients who underwent repeated surgery in patients taking Visanne up to 24 months
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of patients who underwent repeated surgery between stopping Visanne treatment and starting any other treatment than surgery
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Patient’s assessment of overall symptom development using the Clinical Global Impression (CGI) scale
    date_rangeTime Frame:
    At 6 months, 12 months, 24 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

EffectiveNess of VISanne® in improving quality of life in asIan wOmen with eNdometriosis
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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