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

Sponsor
BioSante Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00613002
Collaborator
(none)
597
Enrollment
63
Locations
2
Arms
57
Duration (Months)
9.5
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 :
597 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 :
Dec 1, 2006
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 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. 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. [Baseline and 21-24 weeks.]

    Secondary Outcome Measures

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

    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 topical gel or cream estrogen therapy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 BioSante Site #215 Birmingham Alabama United States 35209
    2 BioSante Site #095 Hoover Alabama United States 35216
    3 BioSante Site #014 Huntsville Alabama United States 35801
    4 BioSante Site #027 Glendale Arizona United States 85308
    5 BioSante Site #040 Tucson Arizona United States 85715
    6 BioSante Site #052 Hot Springs Arkansas United States 71913
    7 BioSante Site #182 Buena Park California United States 90620
    8 BioSante Site #008 San Diego California United States 92108
    9 BioSante Site #007 Denver Colorado United States 80218
    10 BioSante Site #216 Denver Colorado United States 80239
    11 BioSante Site #036 Ridgefield Connecticut United States 06877
    12 BioSante Site #013 Washington District of Columbia United States 20036
    13 BioSante Site #024 Miami Florida United States 33126
    14 BioSante Site #219 Pinellas Park Florida United States 33781
    15 BioSante Site #041 St. Petersburg Florida United States 33709
    16 BioSante Site #009 West Palm Beach Florida United States 33409
    17 BioSante Site #189 Addison Illinois United States 60101
    18 BioSante Site #005 Shreveport Louisiana United States 71115
    19 BioSante Site #004 Baltimore Maryland United States 21285
    20 BioSante Site #044 Detroit Michigan United States 48201
    21 BioSante Site #047 Grand Rapids Michigan United States 49503
    22 BioSante Site #033 Saginaw Michigan United States 48604
    23 BioSante Site #031 St. Clair Shores Michigan United States 48081
    24 BioSante Site #208 Edina Minnesota United States 55435
    25 BioSante Site #198 St. Paul Minnesota United States 55108
    26 BioSante Site #051 Missoula Montana United States 59808
    27 BioSante Site #006 Lincoln Nebraska United States 68501
    28 BioSante Site #217 Las Vegas Nevada United States 89146
    29 BioSante Site #015 Poughkeepsie New York United States 12601
    30 BioSante Site #059 Cary North Carolina United States 27518
    31 BioSante Site #079 Charlotte North Carolina United States 28209
    32 BioSante Site #061 Winston-Salem North Carolina United States 27103
    33 BioSante Site #056 Fargo North Dakota United States 58103
    34 BioSante Site #210 Akron Ohio United States 44311
    35 BioSante Site #212 Cincinnati Ohio United States 45249
    36 BioSante Site #213 Columbus Ohio United States 43212
    37 BioSante Site #050 Eugene Oregon United States 97401
    38 BioSante Site #197 Wexford Pennsylvania United States 15090
    39 BioSante Site #089 Columbia South Carolina United States 29201
    40 BioSante Site #209 Greer South Carolina United States 29651
    41 BioSante Site #097 Hilton Head Island South Carolina United States 29926
    42 BioSante Site #038 Mount Pleasant South Carolina United States 29464
    43 BioSante Site #049 Watertown South Dakota United States 57201
    44 BioSante Site #093 Bristol Tennessee United States 37620
    45 BioSante Site #069 Chattanooga Tennessee United States 37404
    46 BioSante Site #078 Memphis Tennessee United States 38120
    47 BioSante Site #042 Nashville Tennessee United States 37203
    48 BioSante Site #048 Austin Texas United States 78705
    49 BioSante Site #073 Corpus Christi Texas United States 78414
    50 BioSane Site #220 Dallas Texas United States 75231
    51 BioSante Site #039 Houston Texas United States 77054
    52 BioSante Site #211 San Antonio Texas United States 78229
    53 BioSante Site #218 Murray Utah United States 84123
    54 BioSante Site #096 Williston Vermont United States 05495
    55 BioSante Site #003 Charlottesville Virginia United States 22903
    56 BioSante Site #086 Norfolk Virginia United States 23502
    57 BioSante Site #053 Richmond Virginia United States 23294
    58 BioSante Site #090 Virginia Beach Virginia United States 23456
    59 BioSante Site #083 Mountlake Terrace Washington United States 98043
    60 BioSante Site #181 Tacoma Washington United States 98405
    61 BioSante Site #188 Sarnia Ontario Canada N7T 4X3
    62 BioSante Site #054 Windsor Ontario Canada N8W5L7
    63 BioSante Site #193 Shawinigan Quebec Canada G9N 2H6

    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:
    NCT00613002
    Other Study ID Numbers:
    • TESTW006
    First Posted:
    Feb 12, 2008
    Last Update Posted:
    Jan 10, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by BioSante Pharmaceuticals
    hypoactive sexual desire disorder
    testosterone
    menopause
    Additional relevant MeSH terms:
    Hypokinesia
    Disease
    Sexual Dysfunctions, Psychological
    Testosterone

    Study Results

    No Results Posted as of Jan 10, 2013