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 | Region |
|---|---|
| Bayer Healthcare AG | Germany |
| Name | Institution and Institution Address | |
|---|---|---|
| Mark De Guzman | Mark.Deguzman@bayer.com | Bayer Philippines, Inc. 29th Floor, Menarco Tower, 32nd Ave., BGC, Taguig City |
| Name | Institution and Institution Address | |
|---|---|---|
| Mark De Guzman | Mark.Deguzman@bayer.com | 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 |
- 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
0000-00-00
80
Unspecified
Unspecified
2015-04-30
- 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
None
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