A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGelĀ® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.
2011 primary outcome analysis for NDA submission
Yes
Michael C Snabes, MD, PhD
Study Director
BioSante Pharmaceuticals, Inc.
United States: Food and Drug Administration
TESTW007
NCT00612742
January 2008
December 2012
Name | Location |
---|---|
BioSante Site 185 | Birmingham, Alabama 35233 |
BioSante Site #215 | Birmingham, Alabama 35209 |
BioSante Site 095 | Hoover, Alabama 35216 |
BioSante Site #014 | Huntsville, Alabama 35801 |
BioSante Site 196 | Huntsville, Alabama 35802 |
BioSante Site 146 | Mobile, Alabama 33608 |
BioSante Site 027 | Glendale, Arizona 85308 |
BioSante Site 145 | Glendale, Arizona 85306 |
BioSante Site 121 | Phoenix, Arizona 85015 |
BioSante Site 171 | Phoenix, Arizona 85050 |
BioSante Site 040 | Tucson, Arizona 85715 |
BioSante Site 137 | Tucson, Arizona 85710 |
BioSante Site 052 | Hot Springs, Arkansas 71913 |
BioSante Site 100 | Jonesboro, Arkansas 72401 |
BioSante Site 155 | Little Rock, Arkansas 72223 |
BioSante Site 011 | Los Angeles, California 90048 |
BioSante Site 094 | Palm Springs, California 92262 |
BioSante Site 043 | Roseville, California 95661 |
BioSante Site 025 | Sacramento, California 95825 |
BioSante Site 162 | Sacramento, California 95821 |
BioSante Site 112 | San Diego, California 92103 |
BioSante Site 008 | San Diego, California 92108 |
BioSante Site 205 | San Diego, California 92120 |
BioSante Site 159 | Walnut Creek, California 94598 |
BioSante Site 007 | Denver, Colorado 80218 |
BioSante Site 216 | Denver, Colorado 80239 |
BioSante Site 026 | Lakewood, Colorado 80228 |
BioSante Site 166 | Farmington, Connecticut 06032 |
BioSante Site 103 | Hartford, Connecticut 06105 |
BioSante Site 132 | New Britain, Connecticut 06050 |
BioSante Site 151 | New London, Connecticut 06320 |
BioSante Site 036 | Ridgefield, Connecticut 06877 |
BioSante Site 013 | Washington, District of Columbia 20036 |
BioSante Site 118 | Aventura, Florida 33180 |
BioSante Site 139 | Crystal River, Florida 34429 |
BioSante Site 143 | Jacksonville, Florida 32216 |
BioSante Site 180 | Melbourne, Florida 32935 |
BioSante Site 024 | Miami, Florida 33126 |
BioSante Site #219 | Pinellas Park, Florida 33781 |
BioSante Site 041 | St. Petersburg, Florida 33709 |
BioSante Site 009 | West Palm Beach, Florida 33409 |
BioSante Site 115 | Atlanta, Georgia 30342 |
BioSante Site 017 | Meridian, Idaho 83642 |
BioSante Site 189 | Addison, Illinois 60101 |
BioSante Site 156 | Champaign, Illinois 61820 |
BioSante Site 133 | Chicago, Illinois 60654 |
BioSante Site 149 | Chicago, Illinois 60612 |
BioSante Site 045 | Chicago, Illinois 60611 |
BioSante Site 167 | Newburgh, Indiana 47630 |
BioSante Site 022 | South Bend, Indiana 46601 |
BioSante Site 163 | Overland Park, Kansas 66202 |
BioSante Site #214 | Lexington, Kentucky 40504 |
BioSante Site 005 | Shreveport, Louisiana 71115 |
BioSante Site 004 | Baltimore, Maryland 21285 |
BioSante Site 195 | Greenbelt, Maryland 20770 |
BioSante Site 066 | Rockville, Maryland 20850 |
BioSante Site #206 | Fall River, Massachusetts 02720 |
BioSante Site 035 | Ann Arbor, Michigan 48106 |
BioSante Site 124 | Bingham Farms, Michigan 48025 |
BioSante Site 044 | Detroit, Michigan 48201 |
BioSante Site 047 | Grand Rapids, Michigan 49503 |
BioSante Site 105 | Paw Paw, Michigan 49079 |
BioSante Site 033 | Saginaw, Michigan 48604 |
BioSante Site 031 | St. Clair Shores, Michigan 48081 |
BioSante Site #208 | Edina, Minnesota 55435 |
BioSante Site 198 | St. Paul, Minnesota 55108 |
BioSante Site 081 | Olive Branch, Mississippi 38654 |
BioSante Site 104 | St. Louis, Missouri 63141 |
BioSante Site 127 | Billings, Montana 59101 |
BioSante Site 051 | Missoula, Montana 59808 |
BioSante Site 006 | Lincoln, Nebraska 68510 |
BioSante Site 018 | Las Vegas, Nevada 89128 |
BioSante Site #217 | Las Vegas, Nevada 89146 |
BioSante Site 125 | Lawrenceville, New Jersey 08648 |
BioSante Site 179 | Albuquerque, New Mexico 87109 |
BioSante Site 019 | New York, New York 10016 |
BioSante Site 015 | Poughkeepsie, New York 12601 |
BioSante Site 161 | Purchase, New York 10577 |
BioSante Site 079 | Charlotte, North Carolina 28209 |
BioSante Site 072 | Hickory, North Carolina 28601 |
BioSante Site 107 | Raleigh, North Carolina 27612 |
BioSante Site 034 | Winston-Salem, North Carolina 27103 |
BioSante Site 058 | Winston-Salem, North Carolina 27103 |
BioSante Site 061 | Winston-Salem, North Carolina 27103 |
BioSante Site 131 | Winston-Salem, North Carolina 27103 |
BioSante Site 056 | Fargo, North Dakota 58103 |
BioSante Site 071 | Minot, North Dakota 58701 |
BioSante Site #210 | Akron, Ohio 44311 |
BioSante Site #130 | Beachwood, Ohio 44122 |
BioSante Site #212 | Cincinnati, Ohio 45249 |
BioSante Site 101 | Cleveland, Ohio 44122 |
BioSante Site #213 | Columbus, Ohio 43212 |
BioSante Site 160 | Englewood, Ohio 45322 |
BioSante Site 153 | Gallipolis, Ohio 45631 |
BioSante Site 116 | Mayfield Heights, Ohio 44124 |
BioSante Site 138 | West Chester, Ohio 45069 |
BioSante Site 129 | Tulsa, Oklahoma 74104 |
BioSante Site #106 | Eugene, Oregon 97401 |
BioSante Site #050 | Eugene, Oregon 97401 |
BioSante Site 126 | Medford, Oregon 97504 |
BioSante Site 165 | Jenkintown, Pennsylvania 19046 |
BioSante Site 142 | Pittsburgh, Pennsylvania 15206 |
BioSante Site 099 | Sellersville, Pennsylvania 18960 |
BioSante Site 074 | West Reading, Pennsylvania 19611 |
BioSante Site 075 | Warwick, Rhode Island 02886 |
BioSante Site 117 | Anderson, South Carolina 29621 |
BioSante Site 089 | Columbia, South Carolina 29201 |
BioSante Site #209 | Greer, South Carolina 29651 |
BioSante Site 097 | Hilton Head island, South Carolina 29926 |
BioSante Site 038 | Mount Pleasant, South Carolina 29464 |
BioSante Site 093 | Bristol, Tennessee 37620 |
BioSante Site 069 | Chattanooga, Tennessee 37404 |
BioSante Site 002 | Germantown, Tennessee 38139 |
BioSante Site 078 | Memphis, Tennessee 38120 |
BioSante Site 042 | Nashville, Tennessee 37203 |
BioSante Site 048 | Austin, Texas 78705 |
BioSante Site 073 | Corpus Christi, Texas 78414 |
BioSante Site 147 | Dallas, Texas 75234 |
BioSante Site #220 | Dallas, Texas 75231 |
BioSante Site 039 | Houston, Texas 77054 |
BioSante Site 122 | Houston, Texas 77054 |
BioSante Site 154 | Hurst, Texas 76054 |
BioSante Site 084 | San Antonio, Texas 78229 |
BioSante Site #211 | San Antonio, Texas 73229 |
BioSante Site #218 | Murray, Utah 84123 |
BioSante Site 102 | Salt Lake City, Utah 84117 |
BioSante Site 168 | Sandy, Utah 84070 |
BioSante Site 096 | Williston, Vermont 05495 |
BioSante Site 003 | Charlottesville, Virginia 22903 |
BioSante Site 086 | Norfolk, Virginia 23502 |
BioSante Site 053 | Richmond, Virginia 23294 |
BioSante Site 090 | Virginia Beach, Virginia 23456 |
BioSante Site #083 | Mountlake Terrace, Washington 98043 |
BioSante Site 128 | Seattle, Washington 98105 |
BioSante Site #060 | Little Rock, Arkansas 72205 |
BioSante Site #192 | San Diego, California 92128 |
BioSante Site #070 | San Diego, California 92120 |
BioSante Site 152 | Tampa, Florida 33613 |
Biosante Site #136 | Lexington, Kentucky 40536 |
BioSante Site #203 | Portland, Oregon 97227 |
BioSante Site #158 | Milwaukee, Wisconsin 53209 |