Hypoactive Sexual Desire DisorderPhase 3BLOOMNCT00613002
Safety and Efficacy of LibiGel® for the 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 63 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
- 597 participants
- Where
- 63 sitesin 2 countries
- Study dates
- Dec 2006to 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 topical gel or cream estrogen therapy.
Trial locations and contacts
63 sites in 2 countries.
63 sites in 2 countries
United States60 sites
BioSante Site #189
Addison, Illinois, 60101
BioSante Site #210
Akron, Ohio, 44311
BioSante Site #048
Austin, Texas, 78705
BioSante Site #004
Baltimore, Maryland, 21285
BioSante Site #215
Birmingham, Alabama, 35209
BioSante Site #093
Bristol, Tennessee, 37620
BioSante Site #182
Buena Park, California, 90620
BioSante Site #059
Cary, North Carolina, 27518
BioSante Site #079
Charlotte, North Carolina, 28209
BioSante Site #003
Charlottesville, Virginia, 22903
BioSante Site #069
Chattanooga, Tennessee, 37404
BioSante Site #212
Cincinnati, Ohio, 45249
BioSante Site #089
Columbia, South Carolina, 29201
BioSante Site #213
Columbus, Ohio, 43212
BioSante Site #073
Corpus Christi, Texas, 78414
BioSane Site #220
Dallas, Texas, 75231
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 #050
Eugene, Oregon, 97401
BioSante Site #056
Fargo, North Dakota, 58103
BioSante Site #027
Glendale, Arizona, 85308
BioSante Site #047
Grand Rapids, Michigan, 49503
BioSante Site #209
Greer, South Carolina, 29651
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 #014
Huntsville, Alabama, 35801
BioSante Site #217
Las Vegas, Nevada, 89146
BioSante Site #006
Lincoln, Nebraska, 68501
BioSante Site #078
Memphis, Tennessee, 38120
BioSante Site #024
Miami, Florida, 33126
BioSante Site #051
Missoula, Montana, 59808
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 #086
Norfolk, Virginia, 23502
BioSante Site #219
Pinellas Park, Florida, 33781
BioSante Site #015
Poughkeepsie, New York, 12601
BioSante Site #053
Richmond, Virginia, 23294
BioSante Site #036
Ridgefield, Connecticut, 06877
BioSante Site #033
Saginaw, Michigan, 48604
BioSante Site #031
Saint Clair Shores, Michigan, 48081
BioSante Site #198
Saint Paul, Minnesota, 55108
BioSante Site #211
San Antonio, Texas, 78229
BioSante Site #008
San Diego, California, 92108
BioSante Site #005
Shreveport, Louisiana, 71115
BioSante Site #041
St. Petersburg, Florida, 33709
BioSante Site #181
Tacoma, Washington, 98405
BioSante Site #040
Tucson, Arizona, 85715
BioSante Site #090
Virginia Beach, Virginia, 23456
BioSante Site #013
Washington D.C., District of Columbia, 20036
BioSante Site #049
Watertown, South Dakota, 57201
BioSante Site #009
West Palm Beach, Florida, 33409
BioSante Site #197
Wexford, Pennsylvania, 15090
BioSante Site #096
Williston, Vermont, 05495
BioSante Site #061
Winston-Salem, North Carolina, 27103
Canada3 sites
BioSante Site #188
Sarnia, Ontario, N7T 4X3
BioSante Site #193
Shawinigan, Quebec, G9N 2H6
BioSante Site #054
Windsor, Ontario, N8W5L7
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
- hypoactive sexual desire disorder, testosterone, 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 testosterone 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: Baseline and 21-24 weeks.
Secondary outcomes (1)
Change from baseline over time for multiple efficacy measurements
Measured: change over timepoints from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2008 (estimated)
- Study startDec 2006
- 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
- 597 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
- NCT00613002
- Sponsor's protocol ID
- TESTW006
- Acronym
- BLOOM
- Status last verified
- Jan 2013
- First submitted
- 30 Jan 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
- NCT00613002
- Acronym / sponsor ID
- BLOOM / TESTW006
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- hypoactive sexual desire disorder, testosterone, menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- BioSante PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 12 Feb 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 topical 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 testosterone 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: Baseline and 21-24 weeks.
1 secondary outcome
Change from baseline over time for multiple efficacy measurements
Time frame: change over timepoints from baseline
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.
- http://www.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.
63 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 63 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 63 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: 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.