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OpenTrials
Completed

NCT Number: NCT02425462

To Evaluate 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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Multiple Locations, Indonesia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dienogest (Visanne, BAY86-5258)

Drug

Dienogest 2mg daily Oral dose

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

    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

  2. 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

  3. Patient and physician's satisfaction score on Visanne® treatment

    Time frame: At 6 months, 12 months, 24 months

    The subject and physician will be asked to choose any of following; very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied.

  4. Proportion of subjects who continue treatment with Visanne®

    Time frame: At 6 months, 12 months, 24 months

  5. Reasons for stopping of treatment with Visanne®

    Time frame: At 6 months, 12 months, 24 months

  6. 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

  7. Proportion of patients who experienced pain recurrence in patients taking Visanne up to 24 months

    Time frame: Up to 24 months

  8. Time point for first pain recurrence after stopping taking Visanne and before to start any treatment.

    Time frame: Up to 24 months

    Pain recurrence is defined as severity of pain graded > 4 on the 10-point NRS

  9. Proportion of patients who underwent repeated surgery in patients taking Visanne up to 24 months

    Time frame: Up to 24 months

  10. Proportion of patients who underwent repeated surgery between stopping Visanne treatment and starting any other treatment than surgery

    Time frame: Up to 24 months

  11. Patient's assessment of overall symptom development using the Clinical Global Impression (CGI) scale

    Time frame: At 6 months, 12 months, 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: ENVISIOeN

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2015
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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