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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


Phase 3
50 Years
N/A
Not Enrolling
Female
Hypoactive Sexual Desire Disorder

Thank you

Trial Information

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


Inclusion Criteria:



Postmenopausal female subjects

- at least 50 years of age

- with at least two points of cardiovascular risk

- with a clinical diagnosis of HSDD.

Exclusion Criteria:

Subjects must not

- require treatment with anti-androgens, high-dose oral or injectable corticosteroids,
tamoxifen or other selective estrogen receptor modulators,

- have used androgen therapy within 2 months of randomization,

- have a history of estrogen-dependent neoplasia or any gynecologic cancer,

- have a history of cancer of any kind in the past 10 years prior to randomization,

- have a history of malignant melanoma or a history of invasive cancer at any time,

- have a screening mammogram with any finding that requires follow up within 6 months
of randomization,

- have a history of myocardial infarction, coronary revascularization or stroke within
12 months of randomization,

- have any medical condition associated with predicted survival of less than 3 years in
the judgment of the Investigator.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.

Outcome Time Frame:

2011 primary outcome analysis for NDA submission

Safety Issue:

Yes

Principal Investigator

Michael C Snabes, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

BioSante Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

TESTW007

NCT ID:

NCT00612742

Start Date:

January 2008

Completion Date:

December 2012

Related Keywords:

  • Hypoactive Sexual Desire Disorder
  • Cardiovascular event
  • Breast Cancer
  • Testosterone
  • Menopause
  • Hypoactive Sexual Desire Disorder
  • Sexual Dysfunctions, Psychological
  • Hypokinesia

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