A Study to Learn More About Using Dienogest to Treat Endometriosis in Chinese Participants (VISANNE OS)

Bayer

Status: Completed

Conditions: Endometriosis

Treatments: Drug: Dienogest (Visanne,BAY86_5258)

Study type: Observational

Funder types: Industry

Identifiers

NCT04495855

21088

Details and patient eligibility

About

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.

Enrollment: 968 patients

Sex: Female

Volunteers: No Healthy Volunteers

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 design

968 participants in 1 patient group

Visanne treatment

Description:

Patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis, who have been prescribed Visanne

Treatment:

Drug: Dienogest (Visanne,BAY86_5258)