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Brief Title: A Study of Leuprolide to Treat Prostate Cancer
Official Title: A Phase 3, Multi-Center, Open-Label, Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Two 6-Month Leuprolide Formulations, in Subjects With Prostatic Adenocarcinoma
Study ID: NCT00626431
Brief Summary: To assess the efficacy and safety of 2 new formulations of leuprolide acetate 45 mg 6-month depot, Formulation A or Formulation B, for the treatment of patients with prostate cancer. A formulation will be deemed successful if the percentage of subjects with suppression of testosterone to \<= 50 ng/dL from Week 4 to Week 48 is not less than 87%, (the lower bound of the 2-sided 90% confidence interval), a protocol-specified criterion.
Detailed Description: A total of 300 male subjects were planned to be enrolled. Subjects were to receive a total of 2 intramuscular (IM) injections of the same formulation, either Formulation A or Formulation B, administered 24 weeks apart. The first 150 subjects were to receive Formulation A for both injections and the next 150 subjects were to receive Formulation B for both injections. The sponsor was to conduct an ongoing review of the primary endpoint data (suppression of testosterone \<= 50 ng/dL) and planned to stop enrollment of Formulation A or Formulation B, or not to administer the second injection of Formulation A or Formulation B, if 15 or more subjects did not achieve testosterone suppression by Week 4 or failed to maintain testosterone suppression during the treatment period. All analyses and summaries were to be conducted separately for subjects who received Formulation A or Formulation B. This study was to be conducted at approximately 60-80 investigative sites. Subjects participated in the trial for approximately 14 months. This trial was to include a Screening Period (up to 4 weeks), a 12-month Treatment Period (two 6-month treatment cycles), and a Follow-Up Period (30 days).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Site Reference ID/Investigator# 8696, Birmingham, Alabama, United States
Site Reference ID/Investigator# 8681, Homewood, Alabama, United States
Site Reference ID/Investigator# 8569, Anchorage, Alaska, United States
Site Reference ID/Investigator# 9709, Phoenix, Arizona, United States
Site Reference ID/Investigator# 8662, Sierra Vista, Arizona, United States
Site Reference ID/Investigator# 8656, Tucson, Arizona, United States
Site Reference ID/Investigator# 9705, Little Rock, Arkansas, United States
Site Reference ID/Investigator# 8691, Anaheim, California, United States
Site Reference ID/Investigator# 8566, Atherton, California, United States
Site Reference ID/Investigator# 8686, Fresno, California, United States
Site Reference ID/Investigator# 8698, Laguna Hills, California, United States
Site Reference ID/Investigator# 9703, Long Beach, California, United States
Site Reference ID/Investigator# 8674, Los Angeles, California, United States
Site Reference ID/Investigator# 8650, Tarzana, California, United States
Site Reference ID/Investigator# 8699, Torrance, California, United States
Site Reference ID/Investigator# 8668, Denver, Colorado, United States
Site Reference ID/Investigator# 8646, Englewood, Colorado, United States
Site Reference ID/Investigator# 8652, Middlebury, Connecticut, United States
Site Reference ID/Investigator# 8697, New Britain, Connecticut, United States
Site Reference ID/Investigator# 8655, Aventura, Florida, United States
Site Reference ID/Investigator# 8648, Daytona Beach, Florida, United States
Site Reference ID/Investigator# 8660, New Smyrna Beach, Florida, United States
Site Reference ID/Investigator# 8658, Orange City, Florida, United States
Site Reference ID/Investigator# 8664, Orlando, Florida, United States
Site Reference ID/Investigator# 8651, Saint Augustine, Florida, United States
Site Reference ID/Investigator# 8661, St. Petersburg, Florida, United States
Site Reference ID/Investigator# 8568, Tallahassee, Florida, United States
Site Reference ID/Investigator# 8679, Wellington, Florida, United States
Site Reference ID/Investigator# 8562, West Palm Beach, Florida, United States
Site Reference ID/Investigator# 8670, Roswell, Georgia, United States
Site Reference ID/Investigator# 9708, Thomasville, Georgia, United States
Site Reference ID/Investigator# 8693, Fort Wayne, Indiana, United States
Site Reference ID/Investigator# 8690, Newburgh, Indiana, United States
Site Reference ID/Investigator# 8565, Overland Park, Kansas, United States
Site Reference ID/Investigator# 8676, Greenbelt, Maryland, United States
Site Reference ID/Investigator# 8653, Las Vegas, Nevada, United States
Site Reference ID/Investigator# 8667, Lawrenceville, New Jersey, United States
Site Reference ID/Investigator# 9702, Bronx, New York, United States
Site Reference ID/Investigator# 8665, New York, New York, United States
Site Reference ID/Investigator# 8657, Poughkeepsie, New York, United States
Site Reference ID/Investigator# 8680, Charlotte, North Carolina, United States
Site Reference ID/Investigator# 8673, Concord, North Carolina, United States
Site Reference ID/Investigator# 8666, Raleigh, North Carolina, United States
Site Reference ID/Investigator# 8570, Salisbury, North Carolina, United States
Site Reference ID/Investigator# 8644, Winston-Salem, North Carolina, United States
Site Reference ID/Investigator# 8663, Cincinnati, Ohio, United States
Site Reference ID/Investigator# 8567, Columbus, Ohio, United States
Site Reference ID/Investigator# 8678, Bethany, Oklahoma, United States
Site Reference ID/Investigator# 8563, Bala Cynwyd, Pennsylvania, United States
Site Reference ID/Investigator# 8692, Lancaster, Pennsylvania, United States
Site Reference ID/Investigator# 8689, Myrtle Beach, South Carolina, United States
Site Reference ID/Investigator# 8643, Germantown, Tennessee, United States
Site Reference ID/Investigator# 8695, Germantown, Tennessee, United States
Site Reference ID/Investigator# 8685, Memphis, Tennessee, United States
Site Reference ID/Investigator# 8564, Nashville, Tennessee, United States
Site Reference ID/Investigator# 8645, Nashville, Tennessee, United States
Site Reference ID/Investigator# 8641, Dallas, Texas, United States
Site Reference ID/Investigator# 8675, Houston, Texas, United States
Site Reference ID/Investigator# 8684, San Antonio, Texas, United States
Site Reference ID/Investigator# 8649, Tyler, Texas, United States
Site Reference ID/Investigator# 8683, Salt Lake City, Utah, United States
Site Reference ID/Investigator# 8672, Norfolk, Virginia, United States
Site Reference ID/Investigator# 8669, Richmond, Virginia, United States
Name: Kristof Chwalisz, MD, PhD
Affiliation: Abbott
Role: STUDY_DIRECTOR