Hypoactive Sexual Desire DisorderPhase 3BLOOMNCT00657501
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
A Phase 3 study testing testosterone gel in people with Hypoactive Sexual Desire Disorder, run by BioSante Pharmaceuticals at 69 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, 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
- 575 participants
- Where
- 69 sitesin 2 countries
- Study dates
- Mar 2008to Sep 2011
- 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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be between the ages of 30 to 65 years
- Must have undergone hysterectomy and bilateral salpingo-oophorectomy
Who cannot join
- 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 transdermal gel or cream estrogen therapy.
Trial locations and contacts
69 sites in 2 countries.
69 sites in 2 countries
United States66 sites
BioSante Site #117
Anderson, South Carolina, 29621
BioSante Site #035
Ann Arbor, Michigan, 48106
BioSante Site #115
Atlanta, Georgia, 30342
BioSante Site #130
Beachwood, Ohio, 44122
BioSante Site #221
Berkely, California, 94705
BioSante Site #127
Billings, Montana, 59101
BioSante Site #124
Bingham Farms, Michigan, 48025
BioSante Site #156
Champaign, Illinois, 61820
BioSante Site #171
Chandler, Arizona, 85224
BioSante Site #045
Chicago, Illinois, 60611
BioSante Site #149
Chicago, Illinois, 60612
BioSante Site #133
Chicago, Illinois, 60654
BioSante Site #101
Cleveland, Ohio, 44122
BioSante Site #147
Dallas, Texas, 75234
BioSante Site #160
Englewood, Ohio, 45322
BioSante Site #106
Eugene, Oregon, 97401
BioSante Site #166
Farmington, Connecticut, 06032
BioSante Site #153
Gallipolis, Ohio, 45631
BioSante Site #145
Glendale, Arizona, 85306
BioSante Site #122
Houston, Texas, 77054
BioSante Site #154
Hurst, Texas, 76054
BioSante Site #202
Idaho Falls, Idaho, 83404
BioSante Site #143
Jacksonville, Florida, 32216
BioSante Site #165
Jenkintown, Pennsylvania, 19046
BioSante Site #100
Jonesboro, Arkansas, 72401
BioSante Site #105
Kalamazoo, Michigan, 49009
Site #170
Kettering, Ohio, 45429
BioSante Site #026
Lakewood, Colorado, 80228
BioSante Site #114
Las Vegas, Nevada, 89148
BioSante Site #214
Lexington, Kentucky, 40504
BioSante Site #136
Lexington, Kentucky, 40536
BioSante Site #155
Little Rock, Arkansas, 72223
BioSante Site #157
Mandeville, Louisiana, 70471
BioSante Site #116
Mayfield Heights, Ohio, 44124
BioSante Site #126
Medford, Oregon, 97504
BioSante Site #017
Meridian, Idaho, 83642
BioSante Site #110
Metarie, Louisiana, 70006
BioSante Site #146
Mobile, Alabama, 36608
BioSante Site #132
New Britain, Connecticut, 06050
BioSante Site #151
New London, Connecticut, 06320
BioSante Site #167
Newburgh, Indiana, 47630
BioSante Site #120
North Jackson, Tennessee, 38305
BioSante Site #111
Orlando, Florida, 32806
BioSante Site #163
Overland Park, Kansas, 66202
BioSante Site #121
Phoenix, Arizona, 85015
BioSante Site #142
Pittsburgh, Pennsylvania, 15206
BioSante Site #144
Pleasant Grove, Utah, 84062
BioSante Site #203
Portland, Oregon, 97227
BioSante Site #161
Purchase, New York, 10577
BioSante Site #107
Raleigh, North Carolina, 27612
BioSante Site #141
Roswell, Georgia, 30075
BioSante Site #162
Sacramento, California, 95821
BioSante Site #102
Salt Lake City, Utah, 84117
BioSante Site #084
San Antonio, Texas, 78229
BioSante Site #112
San Diego, California, 92103
BioSante Site #128
Seattle, Washington, 98105
BioSante Site #099
Sellersville, Pennsylvania, 18960
BioSante Site #104
St Louis, Missouri, 63141
BioSante Site #152
Tampa, Florida, 33613
BioSante Site #137
Tucson, Arizona, 85710
BioSante Site #129
Tulsa, Oklahoma, 74104
BioSante Site #183
Walla Walla, Washington, 99362
BioSante Site #159
Walnut Creek, California, 94598
BioSante Site #075
Warwick, Rhode Island, 02886
BioSante Site #138
West Chester, Ohio, 45069
BioSante Site #131
Winston-Salem, North Carolina, 27103
Canada3 sites
BioSante Site #123
Ottawa, Ontario, K1H 7W9
BioSante Site #109
Québec, Quebec, G1S 2L6
BioSante Site #175
Vancouver, British Columbia, V6H 3X8
About this study
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
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.
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- testosterone gel, placebo gel
- Keywords
- testosterone, hypoactive sexual desire disorder, menopause
- Medical subject headings
- Sexual Dysfunctions, Psychological
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 gel, 300 mcg
placebo gelDrug
once daily transdermal placebo gel
| Study group | Role | What they receive |
|---|---|---|
| testosterone gel | Experimental | 1% testosterone transdermal gel Receives: Drug: testosterone gel |
| Placebo gel | Placebo comparator | placebo transdermal gel Receives: Drug: placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame: Baseline and 21-24 weeks.
Secondary outcomes (1)
Change from baseline over time for multiple efficacy measurements
Measured: change over timepoints from baseline period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoactive Sexual Desire DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioSante Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael C Snabes, MD, PhD, Study director, BioSante Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657501
- Sponsor's protocol ID
- TESTW008
- Acronym
- BLOOM
- Status last verified
- Jan 2013
- First submitted
- 8 Apr 2008
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00657501
- Acronym / sponsor ID
- BLOOM / TESTW008
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- testosterone, hypoactive sexual desire disorder, menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- BioSante PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| testosterone gel | Experimental | Drug: testosterone gel1% testosterone transdermal gel |
| Placebo gel | Placebo comparator | Drug: placebo gelplacebo transdermal gel |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be between the ages of 30 to 65 years
- Must have undergone hysterectomy and bilateral salpingo-oophorectomy
Key exclusion criteria (5 listed)
- 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 transdermal gel or cream estrogen therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| testosterone gelAlso: LibiGelonce daily transdermal gel, 300 mcg | Drug | testosterone gel |
| placebo gelonce daily transdermal placebo gel | Drug | Placebo gel |
Primary outcome
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.
Time frame: Time Frame: Baseline and 21-24 weeks.
1 secondary outcome
Change from baseline over time for multiple efficacy measurements
Time frame: change over timepoints from baseline period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
- Bloomstudy.comLink provided by the sponsor.
Related trials for Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 2
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
Hypoactive Sexual Desire Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Snabes, MD, PhD study director
BioSante Pharmaceuticals, Inc.
69 sites in 2 countries: see every site and its status.
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 69 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 2 inclusion and 5 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 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 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?
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. (time frame: Time Frame: Baseline and 21-24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2013.