Research Study of a Levonorgestrel 52 MG IUD for the treatment of heavy menstrual bleeding

Research Study of a Levonorgestrel 52 MG IUD  for the treatment of heavy menstrual bleeding

Brief description of study

Healthy women 18 to 50 years of age who are seeking treatment for heavy menstrual bleeding and do not wish to become pregnant during the next ten months are invited to participate.

Detailed description of study

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. 

If you agree to participate, you will be one of about 100 women involved in this study in the United States. You will be one of up to 15 women invited to take part in this study at this study site. Your total participation in the study may last up to approximately 10 months (3 to 4 months screening and 6 months of study treatment). You will need to come to the clinic for up to 8 scheduled visits, and may have 1 contact by telephone or e-mail for follow-up to check on your progress after the end of the treatment. Additional contacts may be made to schedule or confirm your study visits.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    menstrual,heavy period,heavy menstrual,women's health
  • Age: Between 18 Years - 50 Years
  • Gender: Female


Updated on 14 Jul 2023. Study ID: 831878

Interested in the study

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