Submitted by: Maylyn H. Garcia 2015-06-04 00:00:00 Last Updated by: Mark S. de Guzman 2018-06-14 13:54:25 Export to PDF

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

PHRR150731-001017

NCT02425462

Unspecified

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

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.

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2015-04-30 44 2018-12-30 0000-00-00

Ongoing

Institution Classification Region LTO #
Bayer Philippines, Inc. Private Business NCR CDRR-NCR-S-27
Institution Amount Region
Bayer Healthcare AG N/A Germany
Name E-Mail Phone Number Postal Address
Mark De Guzman Mark.Deguzman@bayer.com Tel. (+63 2) 548-5800 Bayer Philippines, Inc. 29th Floor, Menarco Tower, 32nd Ave., BGC, Taguig City
Name E-Mail Phone Number Postal Address
Mark De Guzman Mark.Deguzman@bayer.com Tel. (+63 2) 548-5800 Bayer Philippines, Inc. 29th Floor, Menarco Tower, 32nd Ave., BGC, Taguig City
Name Expertise Affiliation
Maria Jesusa Banal-Silao, MD obstetrics Gynecology St. Luke's Medical Center - Global City
Project Location Institutional Ethics Review Board
St. Luke's Medical Center - Global City N/A

Asian patients at least 18 years of age with clinical or surgical diagnosis of endometriosis, and patients with endometriosis associated pelvic pain.

  • 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 ] [ Designated as 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 [ Time Frame: Baseline and to 24 months ] [ Designated as safety issue: No ]

  • 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 ] [ Designated as safety issue: No ]
    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
  • 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 ] [ Designated as safety issue: No ]
  • Patient and physician's satisfaction score on Visanne® treatment [ Time Frame: At 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    The subject and physician will be asked to choose any of following; very satisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat dissatisfied, very dissatisfied.
  • Proportion of subjects who continue treatment with Visanne® [ Time Frame: At 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • Reasons for stopping of treatment with Visanne® [ Time Frame: At 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Proportion of patients who experienced pain recurrence in patients taking Visanne up to 24 months [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Time point for first pain recurrence after stopping taking Visanne and before to start any treatment. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
    Pain recurrence is defined as severity of pain graded > 4 on the 10-point NRS

Recruiting

  • Indonesia
  • Malaysia
  • Philippines
  • Singapore
  • South Korea
  • Thailand

Clinical Trial

Unspecified

2015-04-29

None

  • 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.

Observational

Unspecified

Unspecified

Non-randomized

Single Blind

Unspecified

Not Applicable

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.

Phase IV

80

Unspecified

Unspecified

30 Apr 2015

Utilization Utilization Info
No records found.

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