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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00613002
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : January 10, 2013
Information provided by (Responsible Party):
BioSante Pharmaceuticals

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
Hypoactive Sexual Desire Disorder Drug: testosterone gel Drug: placebo gel Phase 3

Study Type : Interventional  (Clinical Trial)
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 : December 2006
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: testosterone gel
1% testosterone transdermal gel
Drug: testosterone gel
once daily transdermal testosterone gel, 300 mcg
Other Name: LibiGel

Placebo Comparator: placebo gel
placebo transdermal gel
Drug: placebo gel
once daily transdermal placebo gel

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 [ Time Frame: change over timepoints from baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00613002

  Show 63 Study Locations
Sponsors and Collaborators
BioSante Pharmaceuticals
Study Director: Michael C Snabes, MD, PhD BioSante Pharmaceuticals, Inc.

Additional Information:
Responsible Party: BioSante Pharmaceuticals Identifier: NCT00613002     History of Changes
Other Study ID Numbers: TESTW006
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

Keywords provided by BioSante Pharmaceuticals:
hypoactive sexual desire disorder

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mental Disorders
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents