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Clinical Studies

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  • A Multi-Center, Multi-National Clinical Study to Evaluate the Safety and Effectiveness of the Essure® (Model ESS505) Device to Prevent Pregnancy in Women Who Are Seeking Permanent Contraception Rochester, Minn. This clinical trial is designed to evaluate the safety and effectiveness of the Essure System for Permanent Birth Control (Model ESS505) in preventing pregnancy. The Essure ESS505 is designed to provide immediate permanent contraception. Bayer HealthCare LLC, the study sponsor has modified the design of the commercially available Essure ESS305 into an investigational device, Essure ESS505. The primary design modification for the ESS505 is the addition of a hydrogel component (plug) attached to the distal end of the Essure insert. The hydrogel plug absorbs intrauterine fluids soon after placement, causing the hydrogel to swell, conform to the fallopian tube, and occlude the fallopian tube within one hour. Immediately after the placement procedure, a transvaginal ultrasound (TVU) will be performed to confirm satisfactory location of the insert. In the event that the TVU does not confirm satisfactory placement, a hysterosalpingogram (HSG) will be required to further evaluate the insert location and tubal occlusion. Subjects enrolled in this study will be instructed to rely solely on the ESS505 for contraception after a satisfactory confirmation test is completed.
  • CYP2C9 Gene Polymorphism and Response to Naproxen in Women with Heavy Menstrual Bleeding Rochester, Minn.

    The purpose of this study is to learn more about how individual women metabolize and respond to specific medications such as Naproxen and other NSAIDS. The way individuals metabolize NSAIDS may have a relationship to the effectiveness of Naproxen when used for treatment of heavy menstrual bleeding.

     

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