251
Participants
Start Date
July 31, 2005
Primary Completion Date
May 31, 2009
Study Completion Date
May 31, 2009
Amolimogene
1-dose amolimogene Group: Two intramuscular (IM) injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM placebo injections (approximately 1 mL 0.9% sterile saline) at Weeks 3 and 6 in alternating quadriceps.
Amolimogene
3-dose amolimogene Group: Two IM injections (100 micrograms ZYC101a per injection), one in each quadriceps, at Treatment Initiation. Single IM injections of 100 micrograms ZYC101a at Weeks 3 and 6 in alternating quadriceps.
Placebo
Placebo Group: Two IM placebo injections at Treatment Initiation (1 injection in each quadriceps). Single placebo injections at Weeks 3 and 6 in alternating quadriceps. Each placebo injection consists of approximately 1 mL 0.9% sterile saline.
Temple Center for Women's Health, Philadelphia
Tidewater Clinical Research, Virginia Beach
Lyndhurst Gynecologic Associates, Winston-Salem
Medical College of Georgia, Department of Family Medicine, Augusta
University of Florida, Miami, Miami
Comprehensive Clinical Trials LLC, West Palm Beach
Michael Altenbern, MD, Nashville
Visions Clinical Research, Boynton Beach
Insignia Clinical Research, Tampa
Physician Care Clinical Research, Sarasota
University of Alabama, Birmingham
Sarah Cannon Research, Memphis
University of Minnesota, Minneapolis
The University of Oklahoma Health Sciences Center, Center for Research in Women's Health, Oklahoma City
UT Southwestern Medical Center at Dallas, Dallas
Physicians Research Options, LC, Lakewood
Rosemark Women's Care Specialists, Idaho Falls
Physicians' Research Options, Pleasant Grove
Physicians' Research Options, LLC, Sandy City
Arizona Wellness Center for Women/Precision Trials, LLC, Phoenix
University of Arizona, Tucson
Southwest Clinical Research, Albuquerque
Centennial Hills OB-GYN Associaties, North Las Vegas
Medical Center for Clinical Research, San Diego
The Center for Advanced Research and Education, Inc., Palm Springs
Arrowhead Regional Medical Center, Colton
Eisai Inc.
INDUSTRY