A Study to Learn More About Using Dienogest to Treat Endometriosis in Chinese Participants
VISANNE OS
VISANNE OS/Treatment of Endometriosis With Dienogest in the Real World Clinical Practice
1 other identifier
observational
968
1 country
1
Brief Summary
Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that lines the uterus starts to grow outside of the uterus. This can cause pain during their periods or during sex, and constant pain in the pelvis. Endometriosis can decrease a woman's quality of life and requires long-term treatment to control the symptoms. For some women with endometriosis, symptoms can return after they stop treatment. Or, they may not be able to tolerate the current long-term treatment options. In this study, researchers will find out more about the safety of long-term treatment with dienogest in a large number of Chinese participants. This study will enroll patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis. All of the participants will take dienogest based on their doctor's instructions. They will then visit their doctor's office 3 times over 6 months. During these visits, their doctors will ask them if they have any health problems and about their quality of life. Their doctors will also do tests to measure the pain caused by their endometriosis and any other symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2020
CompletedFirst Posted
Study publicly available on registry
August 3, 2020
CompletedStudy Start
First participant enrolled
October 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2022
CompletedDecember 12, 2023
December 1, 2023
2.2 years
July 14, 2020
December 6, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
The absolute number of AEs reported with Visanne treatment
AE: Adverse Event
From baseline up to 6 months
The absolute number of ADRs reported with Visanne treatment
ADR: Adverse drug reaction
From baseline up to 6 months
The proportion of AEs reported with Visanne treatment
Proportion of each AE will be calculated as number of patients with at least one event divided by the total number of patients.
From baseline up to 6 months
The proportion of ADRs reported with Visanne treatment
Proportion of each ADR will be calculated as number of patients with at least one event divided by the total number of patients.
From baseline up to 6 months
Secondary Outcomes (7)
Changes in Numeric Rating Scale (NRS) score of Endometriosis Associated Pelvic Pain (EAPP) of Visanne treatment
From baseline up to 1,3,6 months
Endometriosis Health Profile-5 (EHP-5) score changes with Visanne treatment
At baseline and 6 months.
Patient and physician's satisfaction score on Visanne® treatment
At 3 and 6 months
Changes in Clinical Global Impression (CGI) scale scores of overall symptom development
At 3 and 6 months
Changes in Patient Global Impression (PGI-C) scale scores of overall symptom development
At 3 and 6 months
- +2 more secondary outcomes
Study Arms (1)
Visanne treatment
Patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis, who have been prescribed Visanne
Interventions
Eligibility Criteria
Chinese patients from post-menarche to menopause diagnosed with endometriosis, either surgically or clinically, and prescribed with Visanne by a physician according to China's health authority approved label.
You may qualify if:
- Signed informed consent.
- Post-menarcheal age through menopause.
- Have clinically or surgically diagnosed endometriosis according to routine clinical practice.
- Decision for the treatment with Visanne was made as per physician's routine treatment practice.
You may not qualify if:
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Any contraindication according to Visanne Chinese label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Many locations
Multiple Locations, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2020
First Posted
August 3, 2020
Study Start
October 28, 2020
Primary Completion
December 23, 2022
Study Completion
December 23, 2022
Last Updated
December 12, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.