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


Phase 3
50 Years
N/A
Not Enrolling
Female
Hypoactive Sexual Desire Disorder

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects.

Outcome Time Frame:

2011 primary outcome analysis for NDA submission

Safety Issue:

Yes

Principal Investigator

Michael C Snabes, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

BioSante Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

TESTW007

NCT ID:

NCT00612742

Start Date:

January 2008

Completion Date:

December 2012

Related Keywords:

  • Hypoactive Sexual Desire Disorder
  • Cardiovascular event
  • Breast Cancer
  • Testosterone
  • Menopause
  • Hypoactive Sexual Desire Disorder
  • Sexual Dysfunctions, Psychological
  • Hypokinesia

Name

Location

BioSante Site 185Birmingham, Alabama  35233
BioSante Site #215Birmingham, Alabama  35209
BioSante Site 095Hoover, Alabama  35216
BioSante Site #014Huntsville, Alabama  35801
BioSante Site 196Huntsville, Alabama  35802
BioSante Site 146Mobile, Alabama  33608
BioSante Site 027Glendale, Arizona  85308
BioSante Site 145Glendale, Arizona  85306
BioSante Site 121Phoenix, Arizona  85015
BioSante Site 171Phoenix, Arizona  85050
BioSante Site 040Tucson, Arizona  85715
BioSante Site 137Tucson, Arizona  85710
BioSante Site 052Hot Springs, Arkansas  71913
BioSante Site 100Jonesboro, Arkansas  72401
BioSante Site 155Little Rock, Arkansas  72223
BioSante Site 011Los Angeles, California  90048
BioSante Site 094Palm Springs, California  92262
BioSante Site 043Roseville, California  95661
BioSante Site 025Sacramento, California  95825
BioSante Site 162Sacramento, California  95821
BioSante Site 112San Diego, California  92103
BioSante Site 008San Diego, California  92108
BioSante Site 205San Diego, California  92120
BioSante Site 159Walnut Creek, California  94598
BioSante Site 007Denver, Colorado  80218
BioSante Site 216Denver, Colorado  80239
BioSante Site 026Lakewood, Colorado  80228
BioSante Site 166Farmington, Connecticut  06032
BioSante Site 103Hartford, Connecticut  06105
BioSante Site 132New Britain, Connecticut  06050
BioSante Site 151New London, Connecticut  06320
BioSante Site 036Ridgefield, Connecticut  06877
BioSante Site 013Washington, District of Columbia  20036
BioSante Site 118Aventura, Florida  33180
BioSante Site 139Crystal River, Florida  34429
BioSante Site 143Jacksonville, Florida  32216
BioSante Site 180Melbourne, Florida  32935
BioSante Site 024Miami, Florida  33126
BioSante Site #219Pinellas Park, Florida  33781
BioSante Site 041St. Petersburg, Florida  33709
BioSante Site 009West Palm Beach, Florida  33409
BioSante Site 115Atlanta, Georgia  30342
BioSante Site 017Meridian, Idaho  83642
BioSante Site 189Addison, Illinois  60101
BioSante Site 156Champaign, Illinois  61820
BioSante Site 133Chicago, Illinois  60654
BioSante Site 149Chicago, Illinois  60612
BioSante Site 045Chicago, Illinois  60611
BioSante Site 167Newburgh, Indiana  47630
BioSante Site 022South Bend, Indiana  46601
BioSante Site 163Overland Park, Kansas  66202
BioSante Site #214Lexington, Kentucky  40504
BioSante Site 005Shreveport, Louisiana  71115
BioSante Site 004Baltimore, Maryland  21285
BioSante Site 195Greenbelt, Maryland  20770
BioSante Site 066Rockville, Maryland  20850
BioSante Site #206Fall River, Massachusetts  02720
BioSante Site 035Ann Arbor, Michigan  48106
BioSante Site 124Bingham Farms, Michigan  48025
BioSante Site 044Detroit, Michigan  48201
BioSante Site 047Grand Rapids, Michigan  49503
BioSante Site 105Paw Paw, Michigan  49079
BioSante Site 033Saginaw, Michigan  48604
BioSante Site 031St. Clair Shores, Michigan  48081
BioSante Site #208Edina, Minnesota  55435
BioSante Site 198St. Paul, Minnesota  55108
BioSante Site 081Olive Branch, Mississippi  38654
BioSante Site 104St. Louis, Missouri  63141
BioSante Site 127Billings, Montana  59101
BioSante Site 051Missoula, Montana  59808
BioSante Site 006Lincoln, Nebraska  68510
BioSante Site 018Las Vegas, Nevada  89128
BioSante Site #217Las Vegas, Nevada  89146
BioSante Site 125Lawrenceville, New Jersey  08648
BioSante Site 179Albuquerque, New Mexico  87109
BioSante Site 019New York, New York  10016
BioSante Site 015Poughkeepsie, New York  12601
BioSante Site 161Purchase, New York  10577
BioSante Site 079Charlotte, North Carolina  28209
BioSante Site 072Hickory, North Carolina  28601
BioSante Site 107Raleigh, North Carolina  27612
BioSante Site 034Winston-Salem, North Carolina  27103
BioSante Site 058Winston-Salem, North Carolina  27103
BioSante Site 061Winston-Salem, North Carolina  27103
BioSante Site 131Winston-Salem, North Carolina  27103
BioSante Site 056Fargo, North Dakota  58103
BioSante Site 071Minot, North Dakota  58701
BioSante Site #210Akron, Ohio  44311
BioSante Site #130Beachwood, Ohio  44122
BioSante Site #212Cincinnati, Ohio  45249
BioSante Site 101Cleveland, Ohio  44122
BioSante Site #213Columbus, Ohio  43212
BioSante Site 160Englewood, Ohio  45322
BioSante Site 153Gallipolis, Ohio  45631
BioSante Site 116Mayfield Heights, Ohio  44124
BioSante Site 138West Chester, Ohio  45069
BioSante Site 129Tulsa, Oklahoma  74104
BioSante Site #106Eugene, Oregon  97401
BioSante Site #050Eugene, Oregon  97401
BioSante Site 126Medford, Oregon  97504
BioSante Site 165Jenkintown, Pennsylvania  19046
BioSante Site 142Pittsburgh, Pennsylvania  15206
BioSante Site 099Sellersville, Pennsylvania  18960
BioSante Site 074West Reading, Pennsylvania  19611
BioSante Site 075Warwick, Rhode Island  02886
BioSante Site 117Anderson, South Carolina  29621
BioSante Site 089Columbia, South Carolina  29201
BioSante Site #209Greer, South Carolina  29651
BioSante Site 097Hilton Head island, South Carolina  29926
BioSante Site 038Mount Pleasant, South Carolina  29464
BioSante Site 093Bristol, Tennessee  37620
BioSante Site 069Chattanooga, Tennessee  37404
BioSante Site 002Germantown, Tennessee  38139
BioSante Site 078Memphis, Tennessee  38120
BioSante Site 042Nashville, Tennessee  37203
BioSante Site 048Austin, Texas  78705
BioSante Site 073Corpus Christi, Texas  78414
BioSante Site 147Dallas, Texas  75234
BioSante Site #220Dallas, Texas  75231
BioSante Site 039Houston, Texas  77054
BioSante Site 122Houston, Texas  77054
BioSante Site 154Hurst, Texas  76054
BioSante Site 084San Antonio, Texas  78229
BioSante Site #211San Antonio, Texas  73229
BioSante Site #218Murray, Utah  84123
BioSante Site 102Salt Lake City, Utah  84117
BioSante Site 168Sandy, Utah  84070
BioSante Site 096Williston, Vermont  05495
BioSante Site 003Charlottesville, Virginia  22903
BioSante Site 086Norfolk, Virginia  23502
BioSante Site 053Richmond, Virginia  23294
BioSante Site 090Virginia Beach, Virginia  23456
BioSante Site #083Mountlake Terrace, Washington  98043
BioSante Site 128Seattle, Washington  98105
BioSante Site #060Little Rock, Arkansas  72205
BioSante Site #192San Diego, California  92128
BioSante Site #070San Diego, California  92120
BioSante Site 152Tampa, Florida  33613
Biosante Site #136Lexington, Kentucky  40536
BioSante Site #203Portland, Oregon  97227
BioSante Site #158Milwaukee, Wisconsin  53209