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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01235754
Other study ID # TESTW009
Secondary ID
Status Completed
Phase Phase 3
First received November 4, 2010
Last updated January 4, 2013
Start date October 2010
Est. completion date January 2012

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

The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.


Recruitment information / eligibility

Status Completed
Enrollment 626
Est. completion date January 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 66 Years
Eligibility Inclusion Criteria:

- must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial

Exclusion Criteria:

- Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion of the Investigator

Study Design

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


Related Conditions & MeSH terms

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

Intervention

Drug:
transdermal testosterone gel 1%
300 mcg once daily transdermal testosterone gel 1%
placebo gel
once daily transdermal placebo gel

Locations

Country Name City State
Canada BioSante Site# 123 Ottawa Ontario
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 #117 Anderson South Carolina
United States BioSante Site #035 Ann Arbor Michigan
United States BioSante Site #115 Atlanta Georgia
United States BioSante Site #048 Austin Texas
United States BioSante Site #130 Beachwood Ohio
United States BioSante Site #221 Berkeley California
United States BioSante Site #127 Billings Montana
United States BioSante Site #124 Bingham Farms Michigan
United States BioSante Site #182 Buena Park California
United States BioSante Site #059 Cary North Carolina
United States BioSante Site #171 Chandler Arizona
United States BioSante Site #003 Charlottesville Virginia
United States BioSante Site #069 Chattanooga Tennessee
United States BioSante Site #133 Chicago Illinois
United States BioSante Site #212 Cincinnati Ohio
United States BioSante Site #101 Cleveland 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 BioSante Site #147 Dallas Texas
United States BioSante Site #220 Dallas Texas
United States BioSante Site #007 Denver Colorado
United States BioSante Site #044 Detroit Michigan
United States BioSante Site #208 Edina Minnesota
United States BioSante Site #160 Englewood Ohio
United States BioSante Site #050 Eugene Oregon
United States BioSante Site #106 Eugene Oregon
United States BioSante Site #206 Fall River Massachusetts
United States BioSante Site #056 Fargo North Dakota
United States BioSante Site #153 Gallipolis Ohio
United States BioSante Site #027 Glendale Arizona
United States BioSante Site #145 Glendale Arizona
United States BioSante Site #047 Grand Rapids Michigan
United States BioSante Site #209 Greer 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 #122 Houston Texas
United States BioSante Site #014 Huntsville Alabama
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 #105 Kalamazoo Michigan
United States BioSante Site #026 Lakewood Colorado
United States BioSante Site #214 Lexington Kentucky
United States BioSante Site #006 Lincoln Nebraska
United States BioSante Site #155 Little Rock Arkansas
United States BioSante Site #126 Medford Oregon
United States BioSante Site #078 Memphis Tennessee
United States BioSante Site #017 Meridian Idaho
United States BioSante Site #110 Metarie Louisiana
United States BioSante Site #024 Miami Florida
United States BioSante Site #051 Missoula Montana
United States BioSante Site #146 Mobile Alabama
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 #132 New Britain Connecticut
United States BioSante Site #151 New London Connecticut
United States BioSante Site #167 Newburgh Indiana
United States BioSante Site #086 Norfolk Virginia
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 #219 Pinellas Park Florida
United States BioSante Site #144 Pleasant Grove Utah
United States BioSante Site #015 Poughkeepsie New York
United States BioSante Site #107 Raleigh North Carolina
United States BioSante Site #053 Richmond Virginia
United States BioSante Site #036 Ridgefield Connecticut
United States BioSante Site #141 Roswell Georgia
United States BioSante Site #162 Sacramento California
United States BioSante Site #033 Saginaw Michigan
United States BioSante Site #102 Salt Lake City Utah
United States BioSante Site #211 San Antonio Texas
United States BioSante Site #008 San Diego California
United States BioSante Site #128 Seattle Washington
United States BioSante Site #099 Sellersville Pennsylvania
United States BioSante Site #005 Shreveport Louisiana
United States BioSante Site #031 St. Clair Shores Michigan
United States BioSante Site #104 St. Louis Missouri
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 #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 #049 Watertown South Dakota
United States BioSante Site #138 West Chester Ohio
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 #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 Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women. 12 weeks No
Secondary change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study This study is to acess the persistence of benefit following the withdrawal of testosterone gel 1% (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women. 12 weeks No
Secondary change from baseline (previous study) in the total number of days with at least one satisfying sexual event at weeks 4 and 8 of the current study This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women. 12 weeks No
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