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

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

This study is currently recruiting participants.

Verified by BioSante Pharmaceuticals, November 2009

First Received: April 8, 2008 Last Updated: November 17, 2009 History of Changes

Sponsor:	BioSante Pharmaceuticals
Information provided by:	BioSante Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00657501

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 gel Drug: placebo gel	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Menopause Surgery

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

U.S. FDA Resources

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: 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 period ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	March 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
testosterone gel: Experimental 1% testosterone transdermal gel	Drug: testosterone gel once daily transdermal gel, 300 mcg
Placebo gel: Placebo Comparator placebo transdermal gel	Drug: placebo gel 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 transdermal gel or cream estrogen therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657501

Contacts

Contact: Joanne Zborowski, Ph.D.

847-478-0500 ext 104

jzborowski@biosantepharma.com

Show 71 Study Locations

Sponsors and Collaborators

BioSante Pharmaceuticals

Investigators

Study Director:

Michael C Snabes, MD, PhD

BioSante Pharmaceuticals, Inc.

More Information

Additional Information:

Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	BioSante Pharmaceuticals, Inc. ( Joanne Zborowski, Director, Clinical Development )
Study ID Numbers:	TESTW008
Study First Received:	April 8, 2008
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00657501 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by BioSante Pharmaceuticals:

testosterone
hypoactive sexual desire disorder
menopause

Additional relevant MeSH terms:

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

Pharmacologic Actions
Testosterone 17 beta-cypionate
Signs and Symptoms
Anabolic Agents
Testosterone
Pathologic Processes
Mental Disorders
Therapeutic Uses
Neurologic Manifestations
Hypokinesia
Androgens

ClinicalTrials.gov processed this record on February 08, 2010