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

Sponsor
BioSante Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00657501
Collaborator
(none)
575
Enrollment
69
Locations
2
Arms
42
Duration (Months)
8.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a randomized, double-blind, placebo-controlled, multi-center study of the safety and efficacy of LibiGel 300mcg in the treatment of HSDD in surgically menopausal women.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
575 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 Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: testosterone gel

1% testosterone transdermal gel

Drug: testosterone gel
once daily transdermal 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. Co-primary endpoints are the change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24, and the change from Baseline to Weeks 21-24 in the mean ISED desire score. [Time Frame: Baseline and 21-24 weeks.]

    Secondary Outcome Measures

    1. Change from baseline over time for multiple efficacy measurements [change over timepoints from baseline period]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Must be between the ages of 30 to 65 years

    • Must have undergone hysterectomy and bilateral salpingo-oophorectomy

    Exclusion Criteria:

    • A history of allergic reactions to androgens (oral or patch), topical alcohol, or any component of the formulation

    • Any systemic skin diseases or local skin abnormalities in the area of application

    • Diagnosed with another primary female sexual dysfunction (e.g., Sexual Aversion Disorder, Female Sexual Arousal Disorder).

    • A medical condition that could affect or interfere with sexual function

    • Using a systemic transdermal gel or cream estrogen therapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BioSante Site #146 Mobile Alabama United States 36608
    2 BioSante Site #171 Chandler Arizona United States 85224
    3 BioSante Site #145 Glendale Arizona United States 85306
    4 BioSante Site #121 Phoenix Arizona United States 85015
    5 BioSante Site #137 Tucson Arizona United States 85710
    6 BioSante Site #100 Jonesboro Arkansas United States 72401
    7 BioSante Site #155 Little Rock Arkansas United States 72223
    8 BioSante Site #221 Berkely California United States 94705
    9 BioSante Site #162 Sacramento California United States 95821
    10 BioSante Site #112 San Diego California United States 92103
    11 BioSante Site #159 Walnut Creek California United States 94598
    12 BioSante Site #026 Lakewood Colorado United States 80228
    13 BioSante Site #166 Farmington Connecticut United States 06032
    14 BioSante Site #132 New Britain Connecticut United States 06050
    15 BioSante Site #151 New London Connecticut United States 06320
    16 BioSante Site #143 Jacksonville Florida United States 32216
    17 BioSante Site #111 Orlando Florida United States 32806
    18 BioSante Site #152 Tampa Florida United States 33613
    19 BioSante Site #115 Atlanta Georgia United States 30342
    20 BioSante Site #141 Roswell Georgia United States 30075
    21 BioSante Site #202 Idaho Falls Idaho United States 83404
    22 BioSante Site #017 Meridian Idaho United States 83642
    23 BioSante Site #156 Champaign Illinois United States 61820
    24 BioSante Site #045 Chicago Illinois United States 60611
    25 BioSante Site #149 Chicago Illinois United States 60612
    26 BioSante Site #133 Chicago Illinois United States 60654
    27 BioSante Site #167 Newburgh Indiana United States 47630
    28 BioSante Site #163 Overland Park Kansas United States 66202
    29 BioSante Site #214 Lexington Kentucky United States 40504
    30 BioSante Site #136 Lexington Kentucky United States 40536
    31 BioSante Site #157 Mandeville Louisiana United States 70471
    32 BioSante Site #110 Metarie Louisiana United States 70006
    33 BioSante Site #035 Ann Arbor Michigan United States 48106
    34 BioSante Site #124 Bingham Farms Michigan United States 48025
    35 BioSante Site #105 Kalamazoo Michigan United States 49009
    36 BioSante Site #104 St. Louis Missouri United States 63141
    37 BioSante Site #127 Billings Montana United States 59101
    38 BioSante Site #114 Las Vegas Nevada United States 89148
    39 BioSante Site #161 Purchase New York United States 10577
    40 BioSante Site #107 Raleigh North Carolina United States 27612
    41 BioSante Site #131 Winston Salem North Carolina United States 27103
    42 BioSante Site #130 Beachwood Ohio United States 44122
    43 BioSante Site #101 Cleveland Ohio United States 44122
    44 BioSante Site #160 Englewood Ohio United States 45322
    45 BioSante Site #153 Gallipolis Ohio United States 45631
    46 Site #170 Kettering Ohio United States 45429
    47 BioSante Site #116 Mayfield Heights Ohio United States 44124
    48 BioSante Site #138 West Chester Ohio United States 45069
    49 BioSante Site #129 Tulsa Oklahoma United States 74104
    50 BioSante Site #106 Eugene Oregon United States 97401
    51 BioSante Site #126 Medford Oregon United States 97504
    52 BioSante Site #203 Portland Oregon United States 97227
    53 BioSante Site #165 Jenkintown Pennsylvania United States 19046
    54 BioSante Site #142 Pittsburgh Pennsylvania United States 15206
    55 BioSante Site #099 Sellersville Pennsylvania United States 18960
    56 BioSante Site #075 Warwick Rhode Island United States 02886
    57 BioSante Site #117 Anderson South Carolina United States 29621
    58 BioSante Site #120 North Jackson Tennessee United States 38305
    59 BioSante Site #147 Dallas Texas United States 75234
    60 BioSante Site #122 Houston Texas United States 77054
    61 BioSante Site #154 Hurst Texas United States 76054
    62 BioSante Site #084 San Antonio Texas United States 78229
    63 BioSante Site #144 Pleasant Grove Utah United States 84062
    64 BioSante Site #102 Salt Lake City Utah United States 84117
    65 BioSante Site #128 Seattle Washington United States 98105
    66 BioSante Site #183 Walla Walla Washington United States 99362
    67 BioSante Site #175 Vancouver British Columbia Canada V6H 3X8
    68 BioSante Site #123 Ottawa Ontario Canada K1H 7W9
    69 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:
    NCT00657501
    Other Study ID Numbers:
    • TESTW008
    First Posted:
    Apr 14, 2008
    Last Update Posted:
    Jan 10, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by BioSante Pharmaceuticals
    testosterone
    hypoactive sexual desire disorder
    menopause
    Additional relevant MeSH terms:
    Hypokinesia
    Disease
    Sexual Dysfunctions, Psychological
    Testosterone

    Study Results

    No Results Posted as of Jan 10, 2013