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

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

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by BioSante Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Change from baseline over time for multiple efficacy measurements [ Time Frame: change over timepoints from baseline ] [ Designated as safety issue: No ]

Enrollment: 597
Study Start Date: December 2006
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: placebo gel


Ages Eligible for Study:   30 Years to 65 Years
Genders 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
Please refer to this study by its identifier: NCT00613002

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

No publications provided

Responsible Party: BioSante Pharmaceuticals Identifier: NCT00613002     History of Changes
Other Study ID Numbers: TESTW006
Study First Received: January 30, 2008
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by BioSante Pharmaceuticals:
hypoactive sexual desire disorder

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents processed this record on April 21, 2014