Our study is testing an investigational vaginal ring that is not yet on the market. The ring is designed to deliver estrogen and a form of progestin called Nestorone. This study will find out how well this product prevents pregnancy and track side effects during ring use. Approximately 370 women will take part in this study at different research centers across the US. If you join the study, you will use the ring for about one year. All study supplies, exams and tests are provided at no cost to you.
Study participation will last a total of about one year and includes at least 12 study visits. At the first visit, you will get more information about the study and complete some paperwork including a detailed medical history. Next, you’ll have a screening exam with a clinician that includes a full physical and gynecologic exam, Pap smear, STD test, urinalysis and fasting blood draw. If you are eligible, you will have an enrollment visit where you will receive your study ring and supplies, including a paper diary that you’ll fill out daily to track your bleeding patterns. Over the course of the study, you will return for eight follow-up visits. There will be six follow-up visits where the clinician will use a transvaginal ultrasound to look at your uterus and ovaries. Each set of three ultrasound visits must occur within a single week. At the end of the study, you will have a final exit visit where you’ll have an exam, repeat tests, and an in-depth interview. We will also be calling you regularly to collect information and keep in touch.
Participants may be compensated up to $1150 over the course of the study.