Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women - Full Text View

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

This study is currently recruiting participants.

Verified by BioSante Pharmaceuticals, December 2008

Sponsored by:	BioSante Pharmaceuticals
Information provided by:	BioSante Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00613002

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 taking a stable dose of estrogen therapy.

Condition	Intervention	Phase
Hypoactive Sexual Desire Disorder	Drug: testosterone Drug: placebo	Phase III

MedlinePlus related topics: Menopause

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by BioSante Pharmaceuticals:

Primary Outcome Measures:

The change in the 4-week total number of satisfying sexual events from the Baseline period to Weeks 21-24. [ 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 ]

Estimated Enrollment:	500
Study Start Date:	December 2006
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. testosterone: Experimental	Drug: testosterone once daily transdermal testosterone gel, 300 mcg
2: Placebo Comparator	Drug: placebo once daily transdermal 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
Must be taking a stable dose of estrogen therapy

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 ClinicalTrials.gov identifier: NCT00613002

Contacts

Contact: Joanne Zborowski

847-478-0500 ext 104

jzborowski@biosantepharma.com

Show 60 Study Locations

Sponsors and Collaborators

BioSante Pharmaceuticals

Investigators

Study Director:

Michael C Snabes, MD, PhD

BioSante Pharmaceuticals, Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	BioSante Pharmaceuticals, Inc. ( Joanne Zborowski, Director, Clinical Development )
Study ID Numbers:	TESTW006
Study First Received:	January 30, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00613002
Health Authority:	United States: Food and Drug Administration

Keywords provided by BioSante Pharmaceuticals:

hypoactive sexual desire disorder
testosterone
menopause

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Signs and Symptoms
Testosterone
Mental Disorders
Neurologic Manifestations

Methyltestosterone
Hypokinesia
Dyskinesias
Menopause
Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Disease
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Sexual and Gender Disorders

Hormones
Pharmacologic Actions
Anabolic Agents
Pathologic Processes
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on January 16, 2009