Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00612742
  4. Details
NCT00612742 Clinical Trial

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

Hypoactive Sexual Desire Disorder Clinical Trial

— BLOOM  

Official title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00612742
Other study ID # TESTW007
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date January 2008
Est. completion date December 2012

Study information
Verified date October 2021
Source BioSante Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Recruitment information / eligibility
Status Completed
Enrollment 3656
Est. completion date December 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility Inclusion Criteria: Postmenopausal female subjects - at least 50 years of age - with at least two points of cardiovascular risk - with a clinical diagnosis of HSDD. Exclusion Criteria: Subjects must not - require treatment with anti-androgens, high-dose oral or injectable corticosteroids, tamoxifen or other selective estrogen receptor modulators, - have used androgen therapy within 2 months of randomization, - have a history of estrogen-dependent neoplasia or any gynecologic cancer, - have a history of cancer of any kind in the past 10 years prior to randomization, - have a history of malignant melanoma or a history of invasive cancer at any time, - have a screening mammogram with any finding that requires follow up within 6 months of randomization, - have a history of myocardial infarction, coronary revascularization or stroke within 12 months of randomization, - have any medical condition associated with predicted survival of less than 3 years in the judgment of the Investigator.

Study Design

Related Conditions & MeSH terms

  • Disease
  • 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 190 Hamilton Ontario
Canada BioSante Site #088 Newmarket Ontario
Canada BioSante Site 088 NewMarket Ontario
Canada BioSante Site 109 Quebec City Quebec
Canada BioSante Site 188 Sarnia Ontario
Canada BioSante Site #175 Vancouver British Columbia
Canada BioSante Site 054 Windsor Ontario
Canada BioSante Site #164 Winnipeg Manitoba
United States BioSante Site 189 Addison Illinois
United States BioSante Site #210 Akron Ohio
United States BioSante Site 179 Albuquerque New Mexico
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 118 Aventura Florida
United States BioSante Site 004 Baltimore Maryland
United States BioSante Site #130 Beachwood Ohio
United States BioSante Site 127 Billings Montana
United States BioSante Site 124 Bingham Farms Michigan
United States BioSante Site #215 Birmingham Alabama
United States BioSante Site 185 Birmingham Alabama
United States BioSante Site 093 Bristol Tennessee
United States BioSante Site 156 Champaign Illinois
United States BioSante Site 171 Chandler Arizona
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 045 Chicago Illinois
United States BioSante Site 133 Chicago Illinois
United States BioSante Site 149 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 139 Crystal River Florida
United States BioSante Site #220 Dallas Texas
United States BioSante Site 147 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 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 166 Farmington Connecticut
United States BioSante Site 153 Gallipolis Ohio
United States BioSante Site 002 Germantown Tennessee
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 195 Greenbelt Maryland
United States BioSante Site #209 Greer South Carolina
United States BioSante Site 103 Hartford Connecticut
United States BioSante Site 072 Hickory North 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 122 Houston Texas
United States BioSante Site #014 Huntsville Alabama
United States BioSante Site 196 Huntsville Alabama
United States BioSante Site 154 Hurst Texas
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 026 Lakewood Colorado
United States BioSante Site #217 Las Vegas Nevada
United States BioSante Site 018 Las Vegas Nevada
United States BioSante Site 125 Lawrenceville New Jersey
United States Biosante Site #136 Lexington Kentucky
United States BioSante Site #214 Lexington Kentucky
United States BioSante Site 006 Lincoln Nebraska
United States BioSante Site #060 Little Rock Arkansas
United States BioSante Site 155 Little Rock Arkansas
United States BioSante Site 011 Los Angeles California
United States BioSante Site 116 Mayfield Heights Ohio
United States BioSante Site 126 Medford Oregon
United States BioSante Site 180 Melbourne Florida
United States BioSante Site 078 Memphis Tennessee
United States BioSante Site 017 Meridian Idaho
United States BioSante Site 024 Miami Florida
United States BioSante Site #158 Milwaukee Wisconsin
United States BioSante Site 071 Minot North Dakota
United States BioSante Site 051 Missoula Montana
United States BioSante Site 146 Mobile Alabama
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 132 New Britain Connecticut
United States BioSante Site 151 New London Connecticut
United States BioSante Site 019 New York New York
United States BioSante Site 167 Newburgh Indiana
United States BioSante Site 086 Norfolk Virginia
United States BioSante Site 081 Olive Branch Mississippi
United States BioSante Site 163 Overland Park Kansas
United States BioSante Site 094 Palm Springs California
United States BioSante Site 105 Paw Paw Michigan
United States BioSante Site 121 Phoenix Arizona
United States BioSante Site #219 Pinellas Park Florida
United States BioSante Site 142 Pittsburgh Pennsylvania
United States BioSante Site #203 Portland Oregon
United States BioSante Site 015 Poughkeepsie New York
United States BioSante Site 161 Purchase 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 066 Rockville Maryland
United States BioSante Site 043 Roseville California
United States BioSante Site 025 Sacramento California
United States BioSante Site 162 Sacramento California
United States BioSante Site 033 Saginaw Michigan
United States BioSante Site 031 Saint Clair Shores Michigan
United States BioSante Site 104 Saint Louis Missouri
United States BioSante Site 198 Saint Paul Minnesota
United States BioSante Site 041 Saint Petersburg Florida
United States BioSante Site 102 Salt Lake City Utah
United States BioSante Site #211 San Antonio Texas
United States BioSante Site 084 San Antonio Texas
United States BioSante Site #070 San Diego California
United States BioSante Site #192 San Diego California
United States BioSante Site 008 San Diego California
United States BioSante Site 112 San Diego California
United States BioSante Site 205 San Diego California
United States BioSante Site 168 Sandy Utah
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 022 South Bend Indiana
United States BioSante Site 152 Tampa Florida
United States BioSante Site 040 Tucson Arizona
United States BioSante Site 137 Tucson Arizona
United States BioSante Site 129 Tulsa Oklahoma
United States BioSante Site 090 Virginia Beach Virginia
United States BioSante Site 159 Walnut Creek California
United States BioSante Site 075 Warwick Rhode Island
United States BioSante Site 013 Washington District of Columbia
United States BioSante Site 138 West Chester Ohio
United States BioSante Site 009 West Palm Beach Florida
United States BioSante Site 074 West Reading Pennsylvania
United States BioSante Site 096 Williston Vermont
United States BioSante Site 034 Winston-Salem North Carolina
United States BioSante Site 058 Winston-Salem North Carolina
United States BioSante Site 061 Winston-Salem North Carolina
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 The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects. 2011 primary outcome analysis for NDA submission
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
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
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 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

External Links