VISANNE OS/Treatment of Endometriosis With Dienogest in the Real World Clinical Practice (VISANNE OS)

  • STATUS
    Recruiting
  • End date
    Oct 30, 2023
  • participants needed
    1000
  • sponsor
    Bayer
Updated on 19 October 2022
endometriosis
dienogest

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.

Details
Condition Endometriosis
Treatment Dienogest (Visanne,BAY86_5258)
Clinical Study IdentifierNCT04495855
SponsorBayer
Last Modified on19 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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