Trial Condition(s):

Endometriosis

A study to learn more about using dienogest to treat endometriosis in Chinese participants (VISANNE OS)

Bayer Identifier:

21088

ClinicalTrials.gov Identifier:

NCT04495855

EudraCT Number:

Not Available

Recruiting

Trial Purpose

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.

Inclusion Criteria
- 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.
Exclusion Criteria
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Any contraindication according to Visanne Chinese label

Trial Summary

Enrollment Goal
1000
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, China

Status
Recruiting
 

Trial Design