Compare Two Copper IUDs

Compare Two Copper IUDs: Mona Lisa NT Cu380 Mini and ParaGard – Active (Not Recruiting)

This is a multi-center, controlled, randomized study comparing the FDA approved, non-hormonal intrauterine device (IUD), the ParaGard®, to an investigational, smaller version of the ParaGard®, called the Mona Lisa NT Cu380 Mini, that is approved in seven countries in Europe and in Canada.

This study aims to determine:

• How well the experimental IUD, the Mona Lisa, prevents pregnancy
• How well the Mona Lisa compares to the currently-used IUD, the ParaGard®, in terms of:
  • Subject satisfaction and continued use
  • Unsuccessful insertion of the IUD and IUD expulsion
  • Changes in symptoms of menstruation, such as vaginal bleeding, menstrual pain, and pelvic pain
  • Participants’ level of pain reported during insertion of the IUD
  • Ease of IUD insertion

The study will take approximately 39 months for each participant to complete. During this time, participants will attend our OB/GYN clinic at BMC for approximately 7 visits, including the placement of the IUD. Participation involves keeping a diary log of menstrual bleeding for the first year of IUD use. Participants are compensated $25 at each study visit, for time and travel.

Healthy women ages 16-40 who are heterosexually active, at risk for pregnancy, and are not at risk for sexually transmitted infections may qualify.

Want more information about this study? Call the BEACON Research Team at 617-383-3500 or email us at dg-infofp@bmc.org.

OB/GYN Clinic, Yawkey Ambulatory Care Center, 5th Floor, Boston Medical Center, 850 Harrison Avenue, Boston, MA 02118
⌨ dg-infofp@bmc.org | ☏ 617-383-3500