The VeraCept IUD Study

STUDY BASICS

Are you a woman aged 18-35 who has regular menstrual cycles and is sexually active? If so, you may be eligible to participate in a research study to help learn more about the comfort, safety, and effectiveness of an investigational intrauterine device (IUD) called VeraCept™. 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. IUDs prevent pregnancy by interfering with sperm movement and egg fertilization. The purpose of this study is to find out how well an investigational IUD called VeraCept™ prevents pregnancy, how easy VeraCept™ is to place in the uterus, and how satisfied women are with using VeraCept™. VeraCept™ is a non-hormonal, low-dose copper-releasing IUD made of a flexible material designed to fit to the shape of the uterus and allow for more comfort during device insertion.

COULD THIS STUDY BE RIGHT FOR YOU?

• Women ages 18-35
• Have regular menstrual cycles (every 21-35 days)
• Sexually active at least once a month with a male partner who has not had a vasectomy
• In a mutually monogamous relationship with male partner for at least the past 3 months
• Not planning to become pregnant in the next 5 years
• Have daily access to an Internet-connected computer, tablet, and/or smartphone

WHAT PARTICIPANTS CAN EXPECT

Following an initial screening visit and IUD placement, participation involves 12 office visits and 27 phone calls or emails over 5 years. Most office visits will last about one hour. Study related procedures include physical exams, pelvic exams, Pap smear (if needed), transvaginal ultrasounds (if needed), urine pregnancy tests, and sexually transmitted disease testing. Participants will also be asked to record daily information about sexual health online on a secure website.