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Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

Sponsor
BioSante Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01235754
Collaborator
(none)
626
Enrollment
102
Locations
2
Arms
15
Duration (Months)
6.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.

Condition or Disease Intervention/Treatment Phase
  • Drug: transdermal testosterone gel 1%
  • Drug: placebo gel
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
626 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Surgically Menopausal Women
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: placebo gel

placebo transdermal gel

Drug: placebo gel
once daily transdermal placebo gel
Other Names:
  • transdermal placebo gel

    		•
    Experimental: testosterone gel

    transdermal testosterone gel

    Drug: transdermal testosterone gel 1%
    300 mcg once daily transdermal testosterone gel 1%
    Other Names:
  • LibiGel transdermal testosterone gel 1%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study [12 weeks]

      This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.

    Secondary Outcome Measures

    1. change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study [12 weeks]

      This study is to acess the persistence of benefit following the withdrawal of testosterone gel 1% (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.

    2. change from baseline (previous study) in the total number of days with at least one satisfying sexual event at weeks 4 and 8 of the current study [12 weeks]

      This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 66 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial
    Exclusion Criteria:
    • Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion of the Investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BioSante Site #095 Hoover Alabama United States 35216
    2 BioSante Site #014 Huntsville Alabama United States 35801
    3 BioSante Site #146 Mobile Alabama United States 36608
    4 BioSante Site #171 Chandler Arizona United States 85224
    5 BioSante Site #145 Glendale Arizona United States 85306
    6 BioSante Site #027 Glendale Arizona United States 85308
    7 BioSante Site #121 Phoenix Arizona United States 85015
    8 BioSante Site #137 Tucson Arizona United States 85710
    9 BioSante Site #052 Hot Springs Arkansas United States 71913
    10 BioSante Site #155 Little Rock Arkansas United States 72223
    11 BioSante Site #221 Berkeley California United States 94705
    12 BioSante Site #182 Buena Park California United States 90620
    13 BioSante Site #162 Sacramento California United States 95821
    14 BioSante Site #008 San Diego California United States 92108
    15 BioSante Site #159 Walnut Creek California United States 94598
    16 BioSante Site #007 Denver Colorado United States 80218
    17 BioSante Site #026 Lakewood Colorado United States 80239
    18 BioSante Site #132 New Britain Connecticut United States 06050
    19 BioSante Site #151 New London Connecticut United States 06320
    20 BioSante Site #036 Ridgefield Connecticut United States 06877
    21 BioSante Site #143 Jacksonville Florida United States 32216
    22 BioSante Site #024 Miami Florida United States 33126
    23 BioSante Site #111 Orlando Florida United States 32806
    24 BioSante Site #219 Pinellas Park Florida United States 33781
    25 BioSante Site #041 St. Petersburg Florida United States 33709
    26 BioSante Site #009 West Palm Beach Florida United States 33409
    27 BioSante Site #115 Atlanta Georgia United States 30342
    28 BioSante Site #141 Roswell Georgia United States 30075
    29 BioSante Site #202 Idaho Falls Idaho United States 83404
    30 BioSante Site #017 Meridian Idaho United States 83642
    31 BioSante Site #189 Addison Illinois United States 60101
    32 BioSante Site #133 Chicago Illinois United States 60654
    33 BioSante Site #167 Newburgh Indiana United States 47630
    34 BioSante Site #163 Overland Park Kansas United States 66202
    35 BioSante Site #214 Lexington Kentucky United States 40504
    36 BioSante Site #110 Metarie Louisiana United States 70006
    37 BioSante Site #005 Shreveport Louisiana United States 71115
    38 BioSante Site #206 Fall River Massachusetts United States 02720
    39 BioSante Site #035 Ann Arbor Michigan United States 48106
    40 BioSante Site #124 Bingham Farms Michigan United States 48025
    41 BioSante Site #044 Detroit Michigan United States 48201
    42 BioSante Site #047 Grand Rapids Michigan United States 49503
    43 BioSante Site #105 Kalamazoo Michigan United States 49009
    44 BioSante Site #033 Saginaw Michigan United States 48604
    45 BioSante Site #031 St. Clair Shores Michigan United States 48081
    46 BioSante Site #208 Edina Minnesota United States 55435
    47 BioSante Site #198 St. Paul Minnesota United States 55108
    48 BioSante Site #104 St. Louis Missouri United States 63141
    49 BioSante Site #127 Billings Montana United States 49101
    50 BioSante Site #051 Missoula Montana United States 59808
    51 BioSante Site #006 Lincoln Nebraska United States 68510
    52 BioSante Site #015 Poughkeepsie New York United States 12601
    53 BioSante Site #059 Cary North Carolina United States 27518
    54 BioSante Site #107 Raleigh North Carolina United States 27612
    55 BioSante Site #131 Winston-Salem North Carolina United States 27103
    56 BioSante Site #056 Fargo North Dakota United States 58103
    57 BioSante Site #210 Akron Ohio United States 44311
    58 BioSante Site #130 Beachwood Ohio United States 44122
    59 BioSante Site #212 Cincinnati Ohio United States 45249
    60 BioSante Site #101 Cleveland Ohio United States 44122
    61 BioSante Site #213 Columbus Ohio United States 43212
    62 BioSante Site #160 Englewood Ohio United States 45322
    63 BioSante Site #153 Gallipolis Ohio United States 45631
    64 BioSante Site #138 West Chester Ohio United States 45069
    65 BioSante Site #129 Tulsa Oklahoma United States 74104
    66 BioSante Site #050 Eugene Oregon United States 97401
    67 BioSante Site #106 Eugene Oregon United States 97401
    68 BioSante Site #126 Medford Oregon United States 97504
    69 BioSante Site #165 Jenkintown Pennsylvania United States 19046
    70 BioSante Site #099 Sellersville Pennsylvania United States 18960
    71 BioSante Site #197 Wexford Pennsylvania United States 15090
    72 BioSante Site #117 Anderson South Carolina United States 29621
    73 BioSante Site #089 Columbia South Carolina United States 29201
    74 BioSante Site #209 Greer South Carolina United States 29651
    75 BioSante Site #049 Watertown South Dakota United States 57201
    76 BioSante Site #069 Chattanooga Tennessee United States 87404
    77 BioSante Site #078 Memphis Tennessee United States 38120
    78 BioSante Site #042 Nashville Tennessee United States 37203
    79 BioSante Site #120 North Jackson Tennessee United States 38305
    80 BioSante Site #048 Austin Texas United States 78705
    81 BioSante Site #073 Corpus Christi Texas United States 78414
    82 BioSante Site #220 Dallas Texas United States 75231
    83 BioSante Site #147 Dallas Texas United States 75234
    84 BioSante Site #039 Houston Texas United States 77054
    85 BioSante Site #122 Houston Texas United States 77054
    86 BioSante Site #154 Hurst Texas United States 76054
    87 BioSante Site #211 San Antonio Texas United States 78229
    88 BioSante Site #218 Murray Utah United States 84123
    89 BioSante Site #144 Pleasant Grove Utah United States 84062
    90 BioSante Site #102 Salt Lake City Utah United States 84117
    91 BioSante Site #096 Williston Vermont United States 05495
    92 BioSante Site #003 Charlottesville Virginia United States 22903
    93 BioSante Site #086 Norfolk Virginia United States 23502
    94 BioSante Site #053 Richmond Virginia United States 23294
    95 BioSante Site #083 Mountlake Terrace Washington United States 98043
    96 BioSante Site #128 Seattle Washington United States 98105
    97 BioSante Site #181 Tacoma Washington United States 98405
    98 BioSante Site #183 Walla Walla Washington United States 99362
    99 BioSante Site# 123 Ottawa Ontario Canada K1H 7W9
    100 BioSante Site #188 Sarnia Ontario Canada N7T 4X3
    101 BioSante Site #054 Windsor Ontario Canada N8W 5L7
    102 BioSante Site #193 Shawinigan Quebec Canada G9N 2H6

    Sponsors and Collaborators

    • BioSante Pharmaceuticals

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BioSante Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT01235754
    Other Study ID Numbers:
    • TESTW009
    First Posted:
    Nov 7, 2010
    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
    Methyltestosterone
    Testosterone
    Testosterone undecanoate
    Testosterone enanthate
    Testosterone 17 beta-cypionate

    Study Results

    No Results Posted as of Jan 10, 2013