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

NCT02425462 | Completed

• 1 other identifier: 17444
• Study Type: observational
• Target: 895
• Locations: 6 countries
• Sites: 6

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (2)

• The mean change from baseline to 6 months of treatment in pain-related Quality of Life measured by EHP-30.

  Baseline and at 6 months

• 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.

  Baseline and to 24 months

Secondary Outcomes (11)

• 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

  Baseline and 6 months,Baseline to 24 months

• Mean change of Endometriosis-associated pelvic pain (EAPP) from baseline in patients with endometriosis either surgically or clinically diagnosed.

  Baseline and 6 months, Baseline and 12 months, Baseline and 24 months

• Patient and physician's satisfaction score on Visanne® treatment

  At 6 months, 12 months, 24 months

• Proportion of subjects who continue treatment with Visanne®

  At 6 months, 12 months, 24 months

• Reasons for stopping of treatment with Visanne®

  At 6 months, 12 months, 24 months

Study Arms (1)

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)

Interventions

Dienogest (Visanne, BAY86-5258) DRUG

Dienogest 2mg daily Oral dose

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (6)

Unknown Facility

Multiple Locations, Indonesia

Location

Unknown Facility

Multiple Locations, Malaysia

Location

Unknown Facility

Multiple Locations, Philippines

Location

Unknown Facility

Multiple Locations, Singapore

Location

Unknown Facility

Multiple Locations, South Korea

Location

Unknown Facility

Multiple Locations, Thailand

Location

Related Publications (2)

• 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.

  PMID: 31096979 RESULT

• 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.

  PMID: 35112299 DERIVED

Related Links

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

MeSH Terms

Conditions

Endometriosis

Interventions

dienogest

Condition Hierarchy (Ancestors)

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

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 24, 2015
• Study Start: April 28, 2015
• Primary Completion: September 28, 2018
• Study Completion: December 14, 2018
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

SG (1); PH (1); KR (1); TH (1); MY (1); ID (1)