CCN016 Copper IUD Study – Ages 18-40

STUDY BASICS

Are you a woman ages 18-40? Are you sexually active with a male partner at least once a month, and do you have regular menstrual periods every 21-35 days? If so, you may be able to participate in a research study to help test the safety, effectiveness, and tolerability of an investigational, non-hormonal, intrauterine device (IUD). Compensation provided.

STUDY PURPOSE

An intrauterine device, or IUD, is a small T-shaped device that is inserted into the uterus for long-term birth control. The most commonly used type of IUD is the copper IUD. The purpose of this study is to help researchers find out how well an experimental copper IUD prevents pregnancy, and how the investigational copper IUD compares to the currently available copper IUD called ParaGard.

COULD THIS STUDY BE RIGHT FOR YOU?

• Women ages 18-40
• Healthy
• Have regular menstrual periods (every 21-35 days)
• Sexually active, with a male partner, at least once per month

WHAT PARTICIPANTS CAN EXPECT

Participation involves about 7 visits and 4 phone calls over 39 months. During the first visit, participants will be randomly assigned (like the flip of a coin) to receive the experimental IUD or the ParaGard IUD. The IUD may also be inserted during this visit. Throughout the study, participants will provide urine samples to test for pregnancy, fill out daily diaries, and answer questions about your period and other health issues. During your final visit, you will be told which IUD you were using. If you were using the experimental IUD, the IUD will be removed unless the study is extended. If you are using the ParaGard IUD, you can continue to use it for an additional 7 years.