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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
  Purpose

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

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613002

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

No publications provided

Responsible Party: BioSante Pharmaceuticals
ClinicalTrials.gov 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
testosterone
menopause

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

ClinicalTrials.gov processed this record on November 20, 2014