Phase 2a Proof Of Concept Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Assessment of Bleeding
The mean change from baseline to the last menstrual cycle during treatment in uterine blood loss.
Day 1
No
Kristof Chwalisz, MD
Study Director
AbbVie
United States: Food and Drug Administration
M12-663
NCT01441635
September 2011
April 2014
Name | Location |
---|---|
Site Reference ID/Investigator# 48144 | Phoenix, Arizona 85015 |
Site Reference ID/Investigator# 50273 | Tucson, Arizona 85712 |
Site Reference ID/Investigator# 50279 | La Mesa, California 91942 |
Site Reference ID/Investigator# 48139 | San Diego, California 92103 |
Site Reference ID/Investigator# 48148 | San Diego, California 92108 |
Site Reference ID/Investigator# 57881 | San Diego, California 92123 |
Site Reference ID/Investigator# 58906 | San Francisco, California 94115 |
Site Reference ID/Investigator# 48142 | Colorado Springs, Colorado 80907 |
Site Reference ID/Investigator# 50275 | Lakewood, Colorado 80228 |
Site Reference ID/Investigator# 48103 | Boynton Beach, Florida 33472 |
Site Reference ID/Investigator# 48163 | New Port Richey, Florida 34652 |
Site Reference ID/Investigator# 58482 | North Miami, Florida 33161 |
Site Reference ID/Investigator# 48140 | South Miami, Florida 33143 |
Site Reference ID/Investigator# 51491 | West Palm Beach, Florida 33409 |
Site Reference ID/Investigator# 58625 | Augusta, Georgia 30909 |
Site Reference ID/Investigator# 48137 | Sandy Springs, Georgia 30328 |
Site Reference ID/Investigator# 48164 | Chicago, Illinois 60612 |
Site Reference ID/Investigator# 48153 | Naperville, Illinois 60540 |
Site Reference ID/Investigator# 54378 | New Orleans, Louisiana 70115 |
Site Reference ID/Investigator# 57559 | Fall River, Massachusetts 02720 |
Site Reference ID/Investigator# 54063 | Saginaw, Michigan 48604 |
Site Reference ID/Investigator# 57558 | Chaska, Minnesota 55318 |
Site Reference ID/Investigator# 50272 | Missoula, Montana 59808 |
Site Reference ID/Investigator# 58622 | Las Vegas, Nevada 89128 |
Site Reference ID/Investigator# 54369 | Plainsboro, New Jersey 08536 |
Site Reference ID/Investigator# 59722 | Brooklyn, New York 11203 |
Site Reference ID/Investigator# 55109 | Durham, North Carolina 27713 |
Site Reference ID/Investigator# 54368 | Raleigh, North Carolina 27612 |
Site Reference ID/Investigator# 48146 | Winston-Salem, North Carolina 27103 |
Site Reference ID/Investigator# 48156 | Winston-Salem, North Carolina 27103 |
Site Reference ID/Investigator# 54375 | Portland, Oregon 97239 |
Site Reference ID/Investigator# 54372 | Jenkintown, Pennsylvania 19046 |
Site Reference ID/Investigator# 50271 | Philadelphia, Pennsylvania 19102 |
Site Reference ID/Investigator# 48102 | Philadelphia, Pennsylvania 19114 |
Site Reference ID/Investigator# 58626 | Bristol, Tennessee 37620 |
Site Reference ID/Investigator# 57561 | Memphis, Tennessee 38119 |
Site Reference ID/Investigator# 54142 | Nashville, Tennessee 37203 |
Site Reference ID/Investigator# 54377 | Dallas, Texas 75390 |
Site Reference ID/Investigator# 48158 | Houston, Texas 77030 |
Site Reference ID/Investigator# 57402 | Houston, Texas 77054 |
Site Reference ID/Investigator# 48145 | San Antonio, Texas 79229 |
Site Reference ID/Investigator# 48168 | Sandy, Utah 84070 |
Site Reference ID/Investigator# 54370 | Norfolk, Virginia 23502 |
Site Reference ID/Investigator# 48160 | Richmond, Virginia 23225 |
Site Reference ID/Investigator# 48149 | Seattle, Washington 98105 |
Site Reference ID/Investigator# 66423 | Carmichael, California 95608 |
Site Reference ID/Investigator# 89654 | Los Angeles, California 90036 |
Site Reference ID/Investigator# 77573 | Debary, Florida 32713 |
Site Reference ID/Investigator# 77575 | Fort Lauderdale, Florida 33316 |
Site Reference ID/Investigator# 65924 | Lake Worth, Florida 33461 |
Site Reference ID/Investigator# 89653 | Nashville, Tennessee 37208 |
Site Reference ID/Investigator# 77574 | Irving, Texas 75061 |