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Clinical Trial Details

Title
M360-L105 - A Phase 3, Multi-center, Open-label Study of a Levonorgestrel 52mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding
Study Purpose
This study will use a hormonal intrauterine system (IUS) that is already on the market in the United States and approved by the Food and Drug Administration (FDA). The IUS is called Liletta® which was approved in August 2017 for women to use for contraception for up to 4 years. This study is being done to evaluate if this IUS is safe and effective treatment for women with heavy menstrual bleeding. 21Liletta is not approved to treat heavy menstrual bleeding and its use in this study is investigational.
Study Plan
The Study Treatment Phase includes insertion of the study IUS and follow-up visits. The Enrollment Visit (Visit 5) is when the study IUS is inserted into your uterus. Procedures performed to evaluate the effectiveness and safety of the study IUS are called “follow-up” procedures. After the Enrollment Visit you will be asked to return to the clinic at about Month 1 (Visit 6), Month 3 (Visit 7), and Month 6 (Visit 8).
Investigators

Principal Investigator
Andrew M. Kaunitz, M.D., FACOG
Obstetrics and Gynecology

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