Asteroid 6 Fibroid Study

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 To take part in this clinical study, you have at least one uterine fibroid diagnosed within the last 3 months and you are suffering from at least one symptom of the uterine fibroid such as; heavy menstrual bleeding or you feel pressure or pain in your lower belly. The purpose of this study is to test the safety and efficacy of the long-term treatment with study drug called vilaprisan in treatment of uterine fibroids and any potential effect it may have on the health of the bones, such as bone loss. Also, this study will test the optimal duration of the treatment with study drug.

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This study is considered research because the study drug has not yet been approved by the FDA in treatment of uterine fibroids. This study is one in a series of studies being done to obtain approval of vilaprisan for use in treatment of uterine fibroids.

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The study involves up to 21 visits to the site and it is expected that you will take part in the study for no more than 21 months.

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You may be eligible to participate if you:

Are 18 years or older

Have uterine fibroids or think you may have uterine fibroids

Experience frequent heavy periods or pelvic pain

 

If you qualify for a uterine fibroids study and decide to participate, you may receive:

Study medication and study-related care at no cost

Close monitoring during regular visits with the study doctor and experienced staff

Feminine hygiene products

Nonhormonal birth control, as needed

Reasonable compensation for time and travel

 

Your participation may also help advance medical knowledge of uterine fibroids.

 

Principal Investigator:
Kurt Barnhart, MD, MSCE

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Sponsor:
Bayer Healthcare Pharmaceuticals Inc.

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Research Coordinator:
Nicole Clayton
215.615.4201
nicole.clayton@uphs.upenn.edu

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