M360

IUD for Heavy Menstrual Bleeding

 

This study is being conducted at The University of Pennsylvania and will use a hormonal intrauterine device (IUD) that is already on the market in the United States.  The IUD is called Liletta®. Liletta was first approved by the Food and Drug Administration (FDA) for contraception (birth control) in 2015.  It is currently approved for women to use for contraception for up to 5 years.  This IUD is a small device with a hormone in it that is placed into your uterus by a study doctor.  The IUD releases a small amount of the hormone into the uterus every day for several years. This investigational drug study is being done to evaluate if this IUD is safe and effective treatment for women with heavy menstrual bleeding. 

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Participation in the study may last up to approximately 10 months (3 to 4 months screening and 6 months of study treatment).

You may be eligible to participate if you:
Are between 18 and 50 years of age 
Experience heavy menstrual periods 
Are not using hormonal contraception

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Study Participation Involves:
•    Up to 8 study site visits
•    Phone and email contact between visits
•    Study related medical, physical and gyn exam
•    Blood tests
•    Insertion of study IUD
•    Daily diary entries
•    Completion of questionnaires

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Qualified participants will receive:
Study IUD, with option for continued use after completion of the study
Menstrual products provided at no cost
$25-100 per completed study visit ($800 total for completing every part of the study)

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Principal Investigator:
Kurt Barnhart, MD, MSCE

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Sponsor:
Medicines360

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Research Coordinators:
Karen Lecks, CRNP: Karen.Lecks@uphs.upenn.edu, 215-349-5201
Jessica McClusky: Jessica.McClusky@uphs.upenn.edu, 215-662-7727

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