If you have been using the Mirena® for contraception, or heavy menstrual bleeding and contraception, for at least 4.5 years (inserted between the dates of December 23, 2012 and June 24, 2013), you may be interested in participating in this clinical research study. The purpose of this study is to learn more about the safety, tolerability, and effectiveness of using the Mirena® past 5 years, for up to 8 years. If you participate, you will be asked to keep your current Mirena® for an additional 3 years beyond the 5 year removal date, and attend 8-12 visits to University Hospitals. Throughout your participation in the study you will also be asked to record information about your health and menstrual bleeding in an electronic diary we provide you with. If you have been prescribed Mirena® for heavy menstrual bleeding and contraception, we will ask you to collect blood samples during specific time frames using a kit we provide you with.
You may be eligible to participate if you:
Are a woman between the ages of 18-33.
- Have had the same Mirena® for at least 4.5 years and are able to get documentation of the original date of insertion and the indication for use.
- Are sexually active with a male partner who has not had a vasectomy.
- Are willing to use the study drug as your main form of contraception.
- Are willing to accept the risk of pregnancy.
If you are eligible and participate in this study, you may receive compensation for your time and travel.
To learn more about the study and to see if you qualify, please contact Margo Riha, BSN, RN at margo.riha@uhhospitals.org or 440-995-3811; or Bridget Ermlich, MSN, RN at bridget.ermlich@uhhospitals.org or 216-844-8091.