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

Sponsor:	BioSante Pharmaceuticals
Information provided by (Responsible Party):	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.

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

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:

MedlinePlus related topics: Menopause

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 ]

Enrollment:	575
Study Start Date:	March 2008
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 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 transdermal gel or cream estrogen therapy.

Contacts and Locations

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

Show 55 Study Locations

Sponsors and Collaborators

BioSante Pharmaceuticals

Investigators

Study Director:

Michael C Snabes, MD, PhD

BioSante Pharmaceuticals, Inc.

More Information

Additional Information:

Bloomstudy.com This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	BioSante Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00657501 History of Changes
Other Study ID Numbers:	TESTW008
Study First Received:	April 8, 2008
Last Updated:	January 3, 2012
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
Hypokinesia
Sexual and Gender Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate

Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on February 09, 2012