The FASTER Study (First Abarelix-Depot Study for Treating Endometriosis Rapidly) is a medical research study into the safety and effectiveness of Abarelix-depot (abarelix), a new investigational drug for relieving pain associated with endometriosis. Abarelix is a pure gonadotropin-releasing hormone (GnRH) antagonist that works by suppressing estrogen production. The primary goal of the study is to determine whether abarelix is capable of relieving pain faster and with less side effects than another drug commonly used to treat this condition, Lupron Depotâ 3.75 mg.

The study will enroll 360 women at approximately 40 sites across the United States. The treatment period will last for 24 weeks, with a 5-visit follow-up period to continue for an additional 48 weeks.

Women may be able to join the FASTER Study if they:

• Are between the ages of 18 and 45
• Have been surgically diagnosed in the past 30 months with endometriosis
• Suffer from endometriosis-related pain (for example, pelvic pain, pain during intercourse or heavy and/or prolonged menstrual bleeding)
• Have had at least two menstrual cycles of 20 to 40 days duration during the past three months

Eligible volunteers will be assigned to one of four treatment groups:

1. 120 mg of abarelix every 4 weeks for 20 weeks
2. 60 mg of abarelix 4 weeks for 20 weeks
3. 30 mg of abarelix every 4 weeks for 20 weeks
4. Lupron Depotâ 3.75 mg every 4 weeks for 20 weeks

Each volunteer will receive thorough medical attention and testing at no cost, although these services are not meant to replace a volunteer’s usual health care. Volunteers will have an opportunity to learn more detailed information about their condition and can contribute to medical research in finding new treatments for endometriosis.

This research study is funded by PRAECIS Pharmaceuticals Incorporated, the makers of abarelix, and their corporate partner Amgen.

Clinical Trial Locations in Northern Illinois:

Peg Pepping (Study Coordinator) & Paul Dmowski, MD (Principal Investigator)
2425 West 22nd Street
Suite 102
Oakbrook, IL 60523
Phone : 630.954.3636
Fax: 630.954.0064

Lynn Nesmith (Study Coordinator) & David Schleicher, MD (Principal Investigator)
University of Illinois, College of Medicine
Dept. of Obstetrics and Gynecology
2780 MacFarlane Road
Rockford, IL 61107
Phone: 815.637.0015
Fax: 815.637.0040