Phase IV Study to Assess the Safety and Effectiveness of Dienogest (Visanne®) Amongst Indian Women With Endometriosis, in Real-world Clinical Practice: the VISAGE Study (VISAGE)

  • STATUS
    Recruiting
  • End date
    Oct 30, 2023
  • participants needed
    160
  • sponsor
    Bayer
Updated on 17 October 2022

Summary

Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that normally covers the inside of the womb grows outside the womb. 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. It also requires long-term treatment to control the symptoms.

The study drug, dienogest, has already been approved as a treatment for endometriosis associated pelvic pain. Sometimes, researchers continue studying a treatment after it has been approved to learn more about its safety.

In this study, the researchers want to learn more about any medical problems the patients have while taking dienogest. To answer this question, the researchers will collect the medical problems the patients have after taking dienogest and that may or may not be related to dienogest. These medical problems are also known as adverse events.

They will also collect information about the endometriosis associated pelvic pain. The pain measured with a standard rating scale called EAPP (endometriosis-associated pelvic pain) before treatment start and after 6 months of treatment will be compared.

The trial will include women with endometriosis associated pelvic pain whose doctors have decided to start treating them with dienogest. It will include about 160 women in India who are at least 18 years old.

All of the patients will take dienogest based on their doctor's instructions. They will then visit their study site 3 times over 6 months. At these visits, their doctors will ask them questions about how they are feeling and what medications they are taking. The doctors will do tests to measure the pain caused by the patients' endometriosis and any other symptoms. The doctors will also do physical examinations and check the patients' overall health.

Details
Condition Endometriosis Associated Pelvic Pain
Treatment Dienogest (BAY86-5258, Visanne)
Clinical Study IdentifierNCT04808843
SponsorBayer
Last Modified on17 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patients in India at least 18 years of age
Clinical or surgical diagnosis of endometriosis: Clinical diagnosis by suggestive symptoms and positive finding in imaging study (Chocolate cyst)
Patients diagnosed with endometriosis associated pelvic pain who have not been previously treated with Dienogest
Decision to initiate treatment with Dienogest was made as per investigator's routine treatment practice
Signed informed consent

Exclusion Criteria

Participation in an investigational program with interventions outside of routine clinical practice
Contra-indications according to the local summary of product characteristics (SPC)
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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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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