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NCT00613002 Clinical Trial

Safety and Efficacy of LibiGel® for the 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 NCT00613002
Other study ID # TESTW006
Secondary ID
Status Completed
Phase Phase 3
First received January 30, 2008
Last updated January 4, 2013
Start date December 2006
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 597
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 topical 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 testosterone gel, 300 mcg
• placebo gel
once daily transdermal placebo gel

Locations
Country Name City State
Canada BioSante Site #188 Sarnia Ontario
Canada BioSante Site #193 Shawinigan Quebec
Canada BioSante Site #054 Windsor Ontario
United States BioSante Site #189 Addison Illinois
United States BioSante Site #210 Akron Ohio
United States BioSante Site #048 Austin Texas
United States BioSante Site #004 Baltimore Maryland
United States BioSante Site #215 Birmingham Alabama
United States BioSante Site #093 Bristol Tennessee
United States BioSante Site #182 Buena Park California
United States BioSante Site #059 Cary North Carolina
United States BioSante Site #079 Charlotte North Carolina
United States BioSante Site #003 Charlottesville Virginia
United States BioSante Site #069 Chattanooga Tennessee
United States BioSante Site #212 Cincinnati Ohio
United States BioSante Site #089 Columbia South Carolina
United States BioSante Site #213 Columbus Ohio
United States BioSante Site #073 Corpus Christi Texas
United States BioSane Site #220 Dallas Texas
United States BioSante Site #007 Denver Colorado
United States BioSante Site #216 Denver Colorado
United States BioSante Site #044 Detroit Michigan
United States BioSante Site #208 Edina Minnesota
United States BioSante Site #050 Eugene Oregon
United States BioSante Site #056 Fargo North Dakota
United States BioSante Site #027 Glendale Arizona
United States BioSante Site #047 Grand Rapids Michigan
United States BioSante Site #209 Greer South Carolina
United States BioSante Site #097 Hilton Head Island South Carolina
United States BioSante Site #095 Hoover Alabama
United States BioSante Site #052 Hot Springs Arkansas
United States BioSante Site #039 Houston Texas
United States BioSante Site #014 Huntsville Alabama
United States BioSante Site #217 Las Vegas Nevada
United States BioSante Site #006 Lincoln Nebraska
United States BioSante Site #078 Memphis Tennessee
United States BioSante Site #024 Miami Florida
United States BioSante Site #051 Missoula Montana
United States BioSante Site #038 Mount Pleasant South Carolina
United States BioSante Site #083 Mountlake Terrace Washington
United States BioSante Site #218 Murray Utah
United States BioSante Site #042 Nashville Tennessee
United States BioSante Site #086 Norfolk Virginia
United States BioSante Site #219 Pinellas Park Florida
United States BioSante Site #015 Poughkeepsie New York
United States BioSante Site #053 Richmond Virginia
United States BioSante Site #036 Ridgefield Connecticut
United States BioSante Site #033 Saginaw Michigan
United States BioSante Site #211 San Antonio Texas
United States BioSante Site #008 San Diego California
United States BioSante Site #005 Shreveport Louisiana
United States BioSante Site #031 St. Clair Shores Michigan
United States BioSante Site #198 St. Paul Minnesota
United States BioSante Site #041 St. Petersburg Florida
United States BioSante Site #181 Tacoma Washington
United States BioSante Site #040 Tucson Arizona
United States BioSante Site #090 Virginia Beach Virginia
United States BioSante Site #013 Washington District of Columbia
United States BioSante Site #049 Watertown South Dakota
United States BioSante Site #009 West Palm Beach Florida
United States BioSante Site #197 Wexford Pennsylvania
United States BioSante Site #096 Williston Vermont
United States BioSante Site #061 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. Baseline and 21-24 weeks. No
Secondary Change from baseline over time for multiple efficacy measurements change over timepoints from baseline No
See also
  Status Clinical Trial Phase
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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
Terminated 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
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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 NCT00657501 - Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women Phase 3
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 NCT00331214 - Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido Phase 3
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