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NCT00657501 Clinical Trial

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

Hypoactive Sexual Desire Disorder Clinical Trial

— BLOOM  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00657501
Other study ID # TESTW008
Secondary ID
Status Completed
Phase Phase 3
First received April 8, 2008
Last updated January 4, 2013
Start date March 2008
Est. completion date September 2011

Study information
Verified date January 2013
Source BioSante Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 575
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Hypoactive Sexual Desire Disorder
  • Hypokinesia
  • Sexual Dysfunctions, Psychological

Intervention

Drug:
• testosterone gel
once daily transdermal gel, 300 mcg
• placebo gel
once daily transdermal placebo gel

Locations
Country Name City State
Canada BioSante Site #123 Ottawa Ontario
Canada BioSante Site #109 Quebec City Quebec
Canada BioSante Site #175 Vancouver British Columbia
United States BioSante Site #117 Anderson South Carolina
United States BioSante Site #035 Ann Arbor Michigan
United States BioSante Site #115 Atlanta Georgia
United States BioSante Site #130 Beachwood Ohio
United States BioSante Site #221 Berkely California
United States BioSante Site #127 Billings Montana
United States BioSante Site #124 Bingham Farms Michigan
United States BioSante Site #156 Champaign Illinois
United States BioSante Site #171 Chandler Arizona
United States BioSante Site #045 Chicago Illinois
United States BioSante Site #133 Chicago Illinois
United States BioSante Site #149 Chicago Illinois
United States BioSante Site #101 Cleveland Ohio
United States BioSante Site #147 Dallas Texas
United States BioSante Site #160 Englewood Ohio
United States BioSante Site #106 Eugene Oregon
United States BioSante Site #166 Farmington Connecticut
United States BioSante Site #153 Gallipolis Ohio
United States BioSante Site #145 Glendale Arizona
United States BioSante Site #122 Houston Texas
United States BioSante Site #154 Hurst Texas
United States BioSante Site #202 Idaho Falls Idaho
United States BioSante Site #143 Jacksonville Florida
United States BioSante Site #165 Jenkintown Pennsylvania
United States BioSante Site #100 Jonesboro Arkansas
United States BioSante Site #105 Kalamazoo Michigan
United States Site #170 Kettering Ohio
United States BioSante Site #026 Lakewood Colorado
United States BioSante Site #114 Las Vegas Nevada
United States BioSante Site #136 Lexington Kentucky
United States BioSante Site #214 Lexington Kentucky
United States BioSante Site #155 Little Rock Arkansas
United States BioSante Site #157 Mandeville Louisiana
United States BioSante Site #116 Mayfield Heights Ohio
United States BioSante Site #126 Medford Oregon
United States BioSante Site #017 Meridian Idaho
United States BioSante Site #110 Metarie Louisiana
United States BioSante Site #146 Mobile Alabama
United States BioSante Site #132 New Britain Connecticut
United States BioSante Site #151 New London Connecticut
United States BioSante Site #167 Newburgh Indiana
United States BioSante Site #120 North Jackson Tennessee
United States BioSante Site #111 Orlando Florida
United States BioSante Site #163 Overland Park Kansas
United States BioSante Site #121 Phoenix Arizona
United States BioSante Site #142 Pittsburgh Pennsylvania
United States BioSante Site #144 Pleasant Grove Utah
United States BioSante Site #203 Portland Oregon
United States BioSante Site #161 Purchase New York
United States BioSante Site #107 Raleigh North Carolina
United States BioSante Site #141 Roswell Georgia
United States BioSante Site #162 Sacramento California
United States BioSante Site #102 Salt Lake City Utah
United States BioSante Site #084 San Antonio Texas
United States BioSante Site #112 San Diego California
United States BioSante Site #128 Seattle Washington
United States BioSante Site #099 Sellersville Pennsylvania
United States BioSante Site #104 St. Louis Missouri
United States BioSante Site #152 Tampa Florida
United States BioSante Site #137 Tucson Arizona
United States BioSante Site #129 Tulsa Oklahoma
United States BioSante Site #183 Walla Walla Washington
United States BioSante Site #159 Walnut Creek California
United States BioSante Site #075 Warwick Rhode Island
United States BioSante Site #138 West Chester Ohio
United States BioSante Site #131 Winston Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
BioSante Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. No
Secondary Change from baseline over time for multiple efficacy measurements change over timepoints from baseline period No
See also
  Status Clinical Trial Phase
Completed NCT02430987 - Low Sexual Desire and Metabolic Syndrome N/A
Completed NCT01432665 - Lybrido for Female Sexual Dysfunction Phase 2
Terminated NCT00551785 - Surveillance Study of Women Taking Intrinsa® Phase 4
Completed NCT03232801 - A Mindfulness-based Intervention for Older Women With Low Sexual Desire N/A
Recruiting NCT04179734 - Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder Phase 4
Active, not recruiting NCT02770768 - Effects of Flibanserin on the Pre- and Post-menopausal Female Brain N/A
Completed NCT01235754 - Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) Phase 3
Completed NCT03287232 - Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) Phase 3
Completed NCT00384046 - Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen Phase 3
Completed NCT00331123 - Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido Phase 3
Recruiting NCT04943068 - A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal) Phase 3
Completed NCT03463707 - BP101 for Adults With Female Sexual Dysfunction Phase 3
Completed NCT01208038 - Testosterone Patch's Effects on the Cardiovascular System and Libido Phase 4
Completed NCT04336891 - Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.
Completed NCT01382719 - Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder Phase 2
Recruiting NCT00916396 - Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder N/A
Completed NCT00034021 - Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction Phase 2
Completed NCT00338312 - Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido Phase 3
Completed NCT00331214 - Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido Phase 3
Recruiting NCT02968342 - Role of Progesterone in Hypoactive Sexual Desire Disorder in Menopausal Women Phase 4