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Hypoactive Sexual Desire DisorderPhase 3BLOOMNCT00612742

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

A Phase 3 study testing testosterone gel in people with Hypoactive Sexual Desire Disorder, run by BioSante Pharmaceuticals at 149 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Hypoactive Sexual Desire Disorder
What is being tested?
testosterone gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,656 participants
Where
149 sitesin 2 countries
Study dates
Jan 2008to Dec 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Postmenopausal female subjects
  • at least 50 years of age
  • with at least two points of cardiovascular risk
  • with a clinical diagnosis of HSDD.

Who cannot join

  • 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,
Show all 9Show fewer
  • 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.

Trial locations and contacts

149 sites in 2 countries.

149 sites in 2 countries

United States141 sites

  • BioSante Site 189

    Addison, Illinois, 60101

  • BioSante Site #210

    Akron, Ohio, 44311

  • BioSante Site 179

    Albuquerque, New Mexico, 87109

  • BioSante Site 117

    Anderson, South Carolina, 29621

  • BioSante Site 035

    Ann Arbor, Michigan, 48106

  • BioSante Site 115

    Atlanta, Georgia, 30342

  • BioSante Site 048

    Austin, Texas, 78705

  • BioSante Site 118

    Aventura, Florida, 33180

  • BioSante Site 004

    Baltimore, Maryland, 21285

  • BioSante Site #130

    Beachwood, Ohio, 44122

  • BioSante Site 127

    Billings, Montana, 59101

  • BioSante Site 124

    Bingham Farms, Michigan, 48025

  • BioSante Site #215

    Birmingham, Alabama, 35209

  • BioSante Site 185

    Birmingham, Alabama, 35233

  • BioSante Site 093

    Bristol, Tennessee, 37620

  • BioSante Site 156

    Champaign, Illinois, 61820

  • BioSante Site 171

    Chandler, Arizona, 85244

  • BioSante Site 079

    Charlotte, North Carolina, 28209

  • BioSante Site 003

    Charlottesville, Virginia, 22903

  • BioSante Site 069

    Chattanooga, Tennessee, 37404

  • BioSante Site 045

    Chicago, Illinois, 60611

  • BioSante Site 149

    Chicago, Illinois, 60612

  • BioSante Site 133

    Chicago, Illinois, 60654

  • BioSante Site #212

    Cincinnati, Ohio, 45249

  • BioSante Site 101

    Cleveland, Ohio, 44122

  • BioSante Site 089

    Columbia, South Carolina, 29201

  • BioSante Site #213

    Columbus, Ohio, 43212

  • BioSante Site 073

    Corpus Christi, Texas, 78414

  • BioSante Site 139

    Crystal River, Florida, 34429

  • BioSante Site #220

    Dallas, Texas, 75231

  • BioSante Site 147

    Dallas, Texas, 75234

  • BioSante Site 007

    Denver, Colorado, 80218

  • BioSante Site 216

    Denver, Colorado, 80239

  • BioSante Site 044

    Detroit, Michigan, 48201

  • BioSante Site #208

    Edina, Minnesota, 55435

  • BioSante Site 160

    Englewood, Ohio, 45322

  • BioSante Site #050

    Eugene, Oregon, 97401

  • BioSante Site #106

    Eugene, Oregon, 97401

  • BioSante Site #206

    Fall River, Massachusetts, 02720

  • BioSante Site 056

    Fargo, North Dakota, 58103

  • BioSante Site 166

    Farmington, Connecticut, 06032

  • BioSante Site 153

    Gallipolis, Ohio, 45631

  • BioSante Site 002

    Germantown, Tennessee, 38139

  • BioSante Site 145

    Glendale, Arizona, 85306

  • BioSante Site 027

    Glendale, Arizona, 85308

  • BioSante Site 047

    Grand Rapids, Michigan, 49503

  • BioSante Site 195

    Greenbelt, Maryland, 20770

  • BioSante Site #209

    Greer, South Carolina, 29651

  • BioSante Site 103

    Hartford, Connecticut, 06105

  • BioSante Site 072

    Hickory, North Carolina, 28601

  • BioSante Site 097

    Hilton Head Island, South Carolina, 29926

  • BioSante Site 095

    Hoover, Alabama, 35216

  • BioSante Site 052

    Hot Springs, Arkansas, 71913

  • BioSante Site 039

    Houston, Texas, 77054

  • BioSante Site 122

    Houston, Texas, 77054

  • BioSante Site #014

    Huntsville, Alabama, 35801

  • BioSante Site 196

    Huntsville, Alabama, 35802

  • BioSante Site 154

    Hurst, Texas, 76054

  • BioSante Site 143

    Jacksonville, Florida, 32216

  • BioSante Site 165

    Jenkintown, Pennsylvania, 19046

  • BioSante Site 100

    Jonesboro, Arkansas, 72401

  • BioSante Site 026

    Lakewood, Colorado, 80228

  • BioSante Site 018

    Las Vegas, Nevada, 89128

  • BioSante Site #217

    Las Vegas, Nevada, 89146

  • BioSante Site 125

    Lawrenceville, New Jersey, 08648

  • BioSante Site #214

    Lexington, Kentucky, 40504

  • Biosante Site #136

    Lexington, Kentucky, 40536

  • BioSante Site 006

    Lincoln, Nebraska, 68510

  • BioSante Site #060

    Little Rock, Arkansas, 72205

  • BioSante Site 155

    Little Rock, Arkansas, 72223

  • BioSante Site 011

    Los Angeles, California, 90048

  • BioSante Site 116

    Mayfield Heights, Ohio, 44124

  • BioSante Site 126

    Medford, Oregon, 97504

  • BioSante Site 180

    Melbourne, Florida, 32935

  • BioSante Site 078

    Memphis, Tennessee, 38120

  • BioSante Site 017

    Meridian, Idaho, 83642

  • BioSante Site 024

    Miami, Florida, 33126

  • BioSante Site #158

    Milwaukee, Wisconsin, 53209

  • BioSante Site 071

    Minot, North Dakota, 58701

  • BioSante Site 051

    Missoula, Montana, 59808

  • BioSante Site 146

    Mobile, Alabama, 33608

  • BioSante Site #083

    Mountlake Terrace, Washington, 98043

  • BioSante Site 038

    Mt. Pleasant, South Carolina, 29464

  • BioSante Site #218

    Murray, Utah, 84123

  • BioSante Site 042

    Nashville, Tennessee, 37203

  • BioSante Site 132

    New Britain, Connecticut, 06050

  • BioSante Site 151

    New London, Connecticut, 06320

  • BioSante Site 019

    New York, New York, 10016

  • BioSante Site 167

    Newburgh, Indiana, 47630

  • BioSante Site 086

    Norfolk, Virginia, 23502

  • BioSante Site 081

    Olive Branch, Mississippi, 38654

  • BioSante Site 163

    Overland Park, Kansas, 66202

  • BioSante Site 094

    Palm Springs, California, 92262

  • BioSante Site 105

    Paw Paw, Michigan, 49079

  • BioSante Site 121

    Phoenix, Arizona, 85015

  • BioSante Site #219

    Pinellas Park, Florida, 33781

  • BioSante Site 142

    Pittsburgh, Pennsylvania, 15206

  • BioSante Site #203

    Portland, Oregon, 97227

  • BioSante Site 015

    Poughkeepsie, New York, 12601

  • BioSante Site 161

    Purchase, New York, 10577

  • BioSante Site 107

    Raleigh, North Carolina, 27612

  • BioSante Site 053

    Richmond, Virginia, 23294

  • BioSante Site 036

    Ridgefield, Connecticut, 06877

  • BioSante Site 066

    Rockville, Maryland, 20850

  • BioSante Site 043

    Roseville, California, 95661

  • BioSante Site 162

    Sacramento, California, 95821

  • BioSante Site 025

    Sacramento, California, 95825

  • BioSante Site 033

    Saginaw, Michigan, 48604

  • BioSante Site 031

    Saint Clair Shores, Michigan, 48081

  • BioSante Site 198

    Saint Paul, Minnesota, 55108

  • BioSante Site 102

    Salt Lake City, Utah, 84117

  • BioSante Site #211

    San Antonio, Texas, 73229

  • BioSante Site 084

    San Antonio, Texas, 78229

  • BioSante Site 112

    San Diego, California, 92103

  • BioSante Site 008

    San Diego, California, 92108

  • BioSante Site #070

    San Diego, California, 92120

  • BioSante Site 205

    San Diego, California, 92120

  • BioSante Site #192

    San Diego, California, 92128

  • BioSante Site 168

    Sandy City, Utah, 84070

  • BioSante Site 128

    Seattle, Washington, 98105

  • BioSante Site 099

    Sellersville, Pennsylvania, 18960

  • BioSante Site 005

    Shreveport, Louisiana, 71115

  • BioSante Site 022

    South Bend, Indiana, 46601

  • BioSante Site 104

    St Louis, Missouri, 63141

  • BioSante Site 041

    St. Petersburg, Florida, 33709

  • BioSante Site 152

    Tampa, Florida, 33613

  • BioSante Site 137

    Tucson, Arizona, 85710

  • BioSante Site 040

    Tucson, Arizona, 85715

  • BioSante Site 129

    Tulsa, Oklahoma, 74104

  • BioSante Site 090

    Virginia Beach, Virginia, 23456

  • BioSante Site 159

    Walnut Creek, California, 94598

  • BioSante Site 075

    Warwick, Rhode Island, 02886

  • BioSante Site 013

    Washington D.C., District of Columbia, 20036

  • BioSante Site 138

    West Chester, Ohio, 45069

  • BioSante Site 009

    West Palm Beach, Florida, 33409

  • BioSante Site 074

    West Reading, Pennsylvania, 19611

  • BioSante Site 096

    Williston, Vermont, 05495

  • BioSante Site 034

    Winston-Salem, North Carolina, 27103

  • BioSante Site 058

    Winston-Salem, North Carolina, 27103

  • BioSante Site 061

    Winston-Salem, North Carolina, 27103

  • BioSante Site 131

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada8 sites

  • BioSante Site 190

    Hamilton, Ontario, L8M 1K7

  • BioSante Site #088

    Newmarket, Ontario, L3Y 5G8

  • BioSante Site 088

    Newmarket, Ontario, L3Y 5G8

  • BioSante Site 109

    Québec, Quebec, G1S 2L6

  • BioSante Site 188

    Sarnia, Ontario, N7T 4X3

  • BioSante Site #175

    Vancouver, British Columbia, V5Z 4E1

  • BioSante Site 054

    Windsor, Ontario, N8W 5L7

  • BioSante Site #164

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

About this study

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

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).

Being tested
testosterone gel, placebo gel
Keywords
Cardiovascular event, Breast Cancer, Testosterone, Menopause, Hypoactive Sexual Desire Disorder
Medical subject headings
Sexual Dysfunctions, Psychological, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • testosterone gelDrug

    Also called LibiGel

    once daily transdermal testosterone gel, 300 mcg

  • placebo gelDrug

    once daily transdermal placebo gel

Study groups in NCT00612742
Study groupRoleWhat they receive
testosterone gelExperimental1% testosterone transdermal gel
Receives: Drug: testosterone gel
placebo gelPlacebo comparatorplacebo transdermal gel
Receives: Drug: placebo gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 2011 primary outcome analysis for NDA submission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionOct 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,656 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00612742
Sponsor's protocol ID
TESTW007
Acronym
BLOOM
Status last verified
Oct 2021
First submitted
23 Jan 2008
Last updated
29 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • White WB, Grady D, Giudice LC, Berry SM, Zborowski J, Snabes MC. A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder. Am Heart J. 2012 Jan;163(1):27-32. doi: 10.1016/j.ahj.2011.09.021. Epub 2011 Nov 21.

    PubMed 22172433

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing testosterone gel in people with Hypoactive Sexual Desire Disorder, run by BioSante Pharmaceuticals at 149 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of adjudicated, predefined cardiovascular events in LibiGel-treated subjects compared to that of placebo-treated subjects. (time frame: 2011 primary outcome analysis for NDA submission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00612742, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.

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