Mirena Extended Use Study
Purpose of the study
The purpose of this study is to research extended use of the Mirena® IUS. Currently, the Mirena® IUS is approved to prevent pregnancy for 5 years. This study will help researchers assess if the Mirena® IUS is effective and safe beyond 5 years and up to 8 years of use. Additionally, researchers hope to learn more about the safety and tolerability of the study IUS.
PI name: John Partridge
Why is the study being done: Mirena® IUS is a highly effective contraceptive method that is currently approved for use in the U.S. for up to 5 years. In addition, Mirena® has been shown to reduce menstrual blood loss. Researchers aim to assess if Mirena® is an effective method of contraception for up to 8 years. Depending on the results, this may allow clinicians to recommend a longer interval between the IUS placements in women. Mirena® can also lessen menstrual blood loss in women who have heavy menstrual flow. Therefore, a sub-study will be conducted to assess whether the effect of Mirena® on menstrual blood loss is maintained beyond 5 years, and up to 8 years of use.
You may be eligible for this study if:
- You are a woman between the ages of 18 and 35
- You are currently using a Mirena® for birth control OR birth control and heavy menstrual blood loss
- You have been using the same Mirena® for at least 4.5 years and are able to show documentation of the original date of insertion and indication for use.
- You are willing to use the study drug as your main form of contraception
- You are sexually active with a male partner who has not had a vasectomy
This study has a commitment duration of 3 years with 8 study visits.
If you qualify and decide to participate, you may receive up to $1,500 if all study visits are completed. To learn more or see if you qualify, call 804-920-0819
To find out more information and to learn if you are qualified to participate, please call Joelle Jensen, RN at 804-920-0819.