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BLOOM: Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Sponsor
BioSante Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00612742
Collaborator
(none)
3,656
Enrollment
149
Locations
2
Arms
59
Duration (Months)
24.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Condition or Disease Intervention/Treatment Phase
  • Drug: testosterone gel
  • Drug: placebo gel
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
3656 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Oct 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: testosterone gel

1% testosterone transdermal gel

Drug: testosterone gel
once daily transdermal testosterone gel, 300 mcg
Other Names:
  • LibiGel

    		•
    Placebo Comparator: placebo gel

    placebo transdermal gel

    Drug: placebo gel
    once daily transdermal placebo gel

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BioSante Site #215 Birmingham Alabama United States 35209
    2 BioSante Site 185 Birmingham Alabama United States 35233
    3 BioSante Site 095 Hoover Alabama United States 35216
    4 BioSante Site #014 Huntsville Alabama United States 35801
    5 BioSante Site 196 Huntsville Alabama United States 35802
    6 BioSante Site 146 Mobile Alabama United States 33608
    7 BioSante Site 171 Chandler Arizona United States 85244
    8 BioSante Site 145 Glendale Arizona United States 85306
    9 BioSante Site 027 Glendale Arizona United States 85308
    10 BioSante Site 121 Phoenix Arizona United States 85015
    11 BioSante Site 137 Tucson Arizona United States 85710
    12 BioSante Site 040 Tucson Arizona United States 85715
    13 BioSante Site 052 Hot Springs Arkansas United States 71913
    14 BioSante Site 100 Jonesboro Arkansas United States 72401
    15 BioSante Site #060 Little Rock Arkansas United States 72205
    16 BioSante Site 155 Little Rock Arkansas United States 72223
    17 BioSante Site 011 Los Angeles California United States 90048
    18 BioSante Site 094 Palm Springs California United States 92262
    19 BioSante Site 043 Roseville California United States 95661
    20 BioSante Site 162 Sacramento California United States 95821
    21 BioSante Site 025 Sacramento California United States 95825
    22 BioSante Site 112 San Diego California United States 92103
    23 BioSante Site 008 San Diego California United States 92108
    24 BioSante Site #070 San Diego California United States 92120
    25 BioSante Site 205 San Diego California United States 92120
    26 BioSante Site #192 San Diego California United States 92128
    27 BioSante Site 159 Walnut Creek California United States 94598
    28 BioSante Site 007 Denver Colorado United States 80218
    29 BioSante Site 216 Denver Colorado United States 80239
    30 BioSante Site 026 Lakewood Colorado United States 80228
    31 BioSante Site 166 Farmington Connecticut United States 06032
    32 BioSante Site 103 Hartford Connecticut United States 06105
    33 BioSante Site 132 New Britain Connecticut United States 06050
    34 BioSante Site 151 New London Connecticut United States 06320
    35 BioSante Site 036 Ridgefield Connecticut United States 06877
    36 BioSante Site 013 Washington District of Columbia United States 20036
    37 BioSante Site 118 Aventura Florida United States 33180
    38 BioSante Site 139 Crystal River Florida United States 34429
    39 BioSante Site 143 Jacksonville Florida United States 32216
    40 BioSante Site 180 Melbourne Florida United States 32935
    41 BioSante Site 024 Miami Florida United States 33126
    42 BioSante Site #219 Pinellas Park Florida United States 33781
    43 BioSante Site 041 Saint Petersburg Florida United States 33709
    44 BioSante Site 152 Tampa Florida United States 33613
    45 BioSante Site 009 West Palm Beach Florida United States 33409
    46 BioSante Site 115 Atlanta Georgia United States 30342
    47 BioSante Site 017 Meridian Idaho United States 83642
    48 BioSante Site 189 Addison Illinois United States 60101
    49 BioSante Site 156 Champaign Illinois United States 61820
    50 BioSante Site 045 Chicago Illinois United States 60611
    51 BioSante Site 149 Chicago Illinois United States 60612
    52 BioSante Site 133 Chicago Illinois United States 60654
    53 BioSante Site 167 Newburgh Indiana United States 47630
    54 BioSante Site 022 South Bend Indiana United States 46601
    55 BioSante Site 163 Overland Park Kansas United States 66202
    56 BioSante Site #214 Lexington Kentucky United States 40504
    57 Biosante Site #136 Lexington Kentucky United States 40536
    58 BioSante Site 005 Shreveport Louisiana United States 71115
    59 BioSante Site 004 Baltimore Maryland United States 21285
    60 BioSante Site 195 Greenbelt Maryland United States 20770
    61 BioSante Site 066 Rockville Maryland United States 20850
    62 BioSante Site #206 Fall River Massachusetts United States 02720
    63 BioSante Site 035 Ann Arbor Michigan United States 48106
    64 BioSante Site 124 Bingham Farms Michigan United States 48025
    65 BioSante Site 044 Detroit Michigan United States 48201
    66 BioSante Site 047 Grand Rapids Michigan United States 49503
    67 BioSante Site 105 Paw Paw Michigan United States 49079
    68 BioSante Site 033 Saginaw Michigan United States 48604
    69 BioSante Site 031 Saint Clair Shores Michigan United States 48081
    70 BioSante Site #208 Edina Minnesota United States 55435
    71 BioSante Site 198 Saint Paul Minnesota United States 55108
    72 BioSante Site 081 Olive Branch Mississippi United States 38654
    73 BioSante Site 104 Saint Louis Missouri United States 63141
    74 BioSante Site 127 Billings Montana United States 59101
    75 BioSante Site 051 Missoula Montana United States 59808
    76 BioSante Site 006 Lincoln Nebraska United States 68510
    77 BioSante Site 018 Las Vegas Nevada United States 89128
    78 BioSante Site #217 Las Vegas Nevada United States 89146
    79 BioSante Site 125 Lawrenceville New Jersey United States 08648
    80 BioSante Site 179 Albuquerque New Mexico United States 87109
    81 BioSante Site 019 New York New York United States 10016
    82 BioSante Site 015 Poughkeepsie New York United States 12601
    83 BioSante Site 161 Purchase New York United States 10577
    84 BioSante Site 079 Charlotte North Carolina United States 28209
    85 BioSante Site 072 Hickory North Carolina United States 28601
    86 BioSante Site 107 Raleigh North Carolina United States 27612
    87 BioSante Site 034 Winston-Salem North Carolina United States 27103
    88 BioSante Site 058 Winston-Salem North Carolina United States 27103
    89 BioSante Site 061 Winston-Salem North Carolina United States 27103
    90 BioSante Site 131 Winston-Salem North Carolina United States 27103
    91 BioSante Site 056 Fargo North Dakota United States 58103
    92 BioSante Site 071 Minot North Dakota United States 58701
    93 BioSante Site #210 Akron Ohio United States 44311
    94 BioSante Site #130 Beachwood Ohio United States 44122
    95 BioSante Site #212 Cincinnati Ohio United States 45249
    96 BioSante Site 101 Cleveland Ohio United States 44122
    97 BioSante Site #213 Columbus Ohio United States 43212
    98 BioSante Site 160 Englewood Ohio United States 45322
    99 BioSante Site 153 Gallipolis Ohio United States 45631
    100 BioSante Site 116 Mayfield Heights Ohio United States 44124
    101 BioSante Site 138 West Chester Ohio United States 45069
    102 BioSante Site 129 Tulsa Oklahoma United States 74104
    103 BioSante Site #050 Eugene Oregon United States 97401
    104 BioSante Site #106 Eugene Oregon United States 97401
    105 BioSante Site 126 Medford Oregon United States 97504
    106 BioSante Site #203 Portland Oregon United States 97227
    107 BioSante Site 165 Jenkintown Pennsylvania United States 19046
    108 BioSante Site 142 Pittsburgh Pennsylvania United States 15206
    109 BioSante Site 099 Sellersville Pennsylvania United States 18960
    110 BioSante Site 074 West Reading Pennsylvania United States 19611
    111 BioSante Site 075 Warwick Rhode Island United States 02886
    112 BioSante Site 117 Anderson South Carolina United States 29621
    113 BioSante Site 089 Columbia South Carolina United States 29201
    114 BioSante Site #209 Greer South Carolina United States 29651
    115 BioSante Site 097 Hilton Head Island South Carolina United States 29926
    116 BioSante Site 038 Mount Pleasant South Carolina United States 29464
    117 BioSante Site 093 Bristol Tennessee United States 37620
    118 BioSante Site 069 Chattanooga Tennessee United States 37404
    119 BioSante Site 002 Germantown Tennessee United States 38139
    120 BioSante Site 078 Memphis Tennessee United States 38120
    121 BioSante Site 042 Nashville Tennessee United States 37203
    122 BioSante Site 048 Austin Texas United States 78705
    123 BioSante Site 073 Corpus Christi Texas United States 78414
    124 BioSante Site #220 Dallas Texas United States 75231
    125 BioSante Site 147 Dallas Texas United States 75234
    126 BioSante Site 039 Houston Texas United States 77054
    127 BioSante Site 122 Houston Texas United States 77054
    128 BioSante Site 154 Hurst Texas United States 76054
    129 BioSante Site #211 San Antonio Texas United States 73229
    130 BioSante Site 084 San Antonio Texas United States 78229
    131 BioSante Site #218 Murray Utah United States 84123
    132 BioSante Site 102 Salt Lake City Utah United States 84117
    133 BioSante Site 168 Sandy Utah United States 84070
    134 BioSante Site 096 Williston Vermont United States 05495
    135 BioSante Site 003 Charlottesville Virginia United States 22903
    136 BioSante Site 086 Norfolk Virginia United States 23502
    137 BioSante Site 053 Richmond Virginia United States 23294
    138 BioSante Site 090 Virginia Beach Virginia United States 23456
    139 BioSante Site #083 Mountlake Terrace Washington United States 98043
    140 BioSante Site 128 Seattle Washington United States 98105
    141 BioSante Site #158 Milwaukee Wisconsin United States 53209
    142 BioSante Site #175 Vancouver British Columbia Canada V5Z 4E1
    143 BioSante Site #164 Winnipeg Manitoba Canada R3A 1M3
    144 BioSante Site 190 Hamilton Ontario Canada L8M 1K7
    145 BioSante Site #088 Newmarket Ontario Canada L3Y 5G8
    146 BioSante Site 088 NewMarket Ontario Canada L3Y 5G8
    147 BioSante Site 188 Sarnia Ontario Canada N7T 4X3
    148 BioSante Site 054 Windsor Ontario Canada N8W 5L7
    149 BioSante Site 109 Quebec City Quebec Canada G1S 2L6

    Sponsors and Collaborators

    • BioSante Pharmaceuticals

    Investigators

    • Study Director: Michael C Snabes, MD, PhD, BioSante Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    BioSante Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00612742
    Other Study ID Numbers:
    • TESTW007
    First Posted:
    Feb 12, 2008
    Last Update Posted:
    Oct 29, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by BioSante Pharmaceuticals
    Cardiovascular event
    Breast Cancer
    Testosterone
    Menopause
    Hypoactive Sexual Desire Disorder
    Additional relevant MeSH terms:
    Hypokinesia
    Disease
    Sexual Dysfunctions, Psychological
    Testosterone

    Study Results

    No Results Posted as of Oct 29, 2021