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

• ClinicalTrials.gov Identifier: NCT02425462
• Recruitment Status: Completed
• First Posted: April 24, 2015
• Last Update Posted: September 25, 2019
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment
Endometriosis	Drug: Dienogest (Visanne, BAY86-5258)

Study Design

• Study Type: Observational
• Actual Enrollment: 895 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: EffectiveNess of VISanne® in Improving Quality of Life in asIan wOmen With eNdometriosis
• Actual Study Start Date: April 28, 2015
• Actual Primary Completion Date: September 28, 2018
• Actual Study Completion Date: December 14, 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
Cohort 1; Asian patients at least 18 years of age with clinical or surgical diagnosis of endometriosis, and patients with endometriosis associated pelvic pain.	Drug: Dienogest (Visanne, BAY86-5258); Dienogest 2mg daily Oral dose

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• 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

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.

Contacts and Locations

Locations

Indonesia

Multiple Locations, Indonesia

Korea, Republic of

Multiple Locations, Korea, Republic of

Malaysia

Multiple Locations, Malaysia

Philippines

Multiple Locations, Philippines

Singapore

Multiple Locations, Singapore

Thailand

Multiple Locations, Thailand

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Additional Information:

Click here to find results for studies related to Bayer products. 

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02425462
• Other Study ID Numbers: 17444
• First Posted: April 24, 2015
• Last Update Posted: September 25, 2019
• Last Verified: September 2019

Additional relevant MeSH terms:

Endometriosis; Dienogest; Contraceptive Agents, Male; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptives, Oral, Hormonal; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents, Hormonal; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents