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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioSante Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00613002
First received: January 30, 2008
Last updated: January 4, 2013
Last verified: January 2013
History of Changes

January 30, 2008
January 4, 2013
December 2006
September 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
The change in the 4-week total number of days with at least one satisfying sexual event from the Baseline period to Weeks 21-24. [ Time Frame: Baseline and 21-24 weeks. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00613002 on ClinicalTrials.gov Archive Site
Change from baseline over time for multiple efficacy measurements [ Time Frame: change over timepoints from baseline ] [ Designated as safety issue: No ]
Change from baseline over time for multiple efficacy measurements [ Time Frame: change over timepoints from baseline period to weeks 21-24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
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

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypoactive Sexual Desire Disorder
  • Drug: testosterone gel
    once daily transdermal testosterone gel, 300 mcg
    Other Name: LibiGel
  • Drug: placebo gel
    once daily transdermal placebo gel
    Other Name: placebo gel
  • Experimental: testosterone gel
    1% testosterone transdermal gel
    Intervention: Drug: testosterone gel
  • Placebo Comparator: placebo gel
    placebo transdermal gel
    Intervention: Drug: placebo gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
597
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Female
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00613002
TESTW006
No
BioSante Pharmaceuticals
BioSante Pharmaceuticals
Not Provided
Study Director: Michael C Snabes, MD, PhD BioSante Pharmaceuticals, Inc.
BioSante Pharmaceuticals
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP