Clinical trial NCT02425462: To Evaluate Effectiveness of Visanne in Improving Quality of Life in Asian Women With Endometriosis
Official title: EffectiveNess of VISanne® in Improving Quality of Life in asIan wOmen With eNdometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 895
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asian patients at least 18 years of age with Clinical or surgical diagnosis of endometriosis, and patients with endometriosis associated pelvic pain

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: The mean change from baseline to 6 months of treatment in pain-related Quality of Life measured by EHP-30.
timeFrame: Baseline and at 6 months
measure: 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.
timeFrame: Baseline and to 24 months
Secondary outcomes:
measure: 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
timeFrame: Baseline and 6 months,Baseline to 24 months
measure: Mean change of Endometriosis-associated pelvic pain (EAPP) from baseline in patients with endometriosis either surgically or clinically diagnosed.
timeFrame: Baseline and 6 months, Baseline and 12 months, Baseline and 24 months
measure: Patient and physician's satisfaction score on Visanne® treatment
timeFrame: At 6 months, 12 months, 24 months
measure: Proportion of subjects who continue treatment with Visanne®
timeFrame: At 6 months, 12 months, 24 months
measure: Reasons for stopping of treatment with Visanne®
timeFrame: At 6 months, 12 months, 24 months
measure: Proportion of patients with amenorrhea, intermenstrual bleeding/spotting or irregular bleeding while treatment with Visanne®
timeFrame: At 1 month, 3 months, 6 months, 12 months, and 24 months
measure: Proportion of patients who experienced pain recurrence in patients taking Visanne up to 24 months
timeFrame: Up to 24 months
measure: Time point for first pain recurrence after stopping taking Visanne and before to start any treatment.
timeFrame: Up to 24 months
measure: Proportion of patients who underwent repeated surgery in patients taking Visanne up to 24 months
timeFrame: Up to 24 months
measure: Proportion of patients who underwent repeated surgery between stopping Visanne treatment and starting any other treatment than surgery
timeFrame: Up to 24 months
measure: Patient's assessment of overall symptom development using the Clinical Global Impression (CGI) scale
timeFrame: At 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: Indonesia
city: Multiple Locations
country: Korea, Republic of
city: Multiple Locations
country: Malaysia
city: Multiple Locations
country: Philippines
city: Multiple Locations
country: Singapore
city: Multiple Locations
country: Thailand
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Techatraisak K, Hestiantoro A, Ruey S, Banal-Silao MJ, Kim MR, Seong SJ, Thaufik S, Ahlers C, Shin SY, Lee BS. Effectiveness of dienogest in improving quality of life in Asian women with endometriosis (ENVISIOeN): interim results from a prospective cohort study under real-life clinical practice. BMC Womens Health. 2019 May 16;19(1):68. doi: 10.1186/s12905-019-0758-6.
citation: Techatraisak K, Hestiantoro A, Soon R, Banal-Silao MJ, Kim MR, Seong SJ, Hidayat ST, Cai L, Shin S, Lee BS. Impact of Long-Term Dienogest Therapy on Quality of Life in Asian Women with Endometriosis: the Prospective Non-Interventional Study ENVISIOeN. Reprod Sci. 2022 Apr;29(4):1157-1169. doi: 10.1007/s43032-021-00787-w. Epub 2022 Feb 2.