Hypoactive Sexual Desire DisorderPhase 3NCT01235754
Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)
A Phase 3 study testing transdermal testosterone gel 1% in people with Hypoactive Sexual Desire Disorder, run by BioSante Pharmaceuticals at 102 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women. Read more about this study
- Who is it for?
- Ages 30 to 66 years, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder
- What is being tested?
- transdermal testosterone gel 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 626 participants
- Where
- 102 sitesin 2 countries
- Study dates
- Oct 2010to Jan 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 30 to 66 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial
Who cannot join
- Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion of the Investigator
Trial locations and contacts
102 sites in 2 countries.
102 sites in 2 countries
United States98 sites
BioSante Site #189
Addison, Illinois, 60101
BioSante Site #210
Akron, Ohio, 44311
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 #130
Beachwood, Ohio, 44122
BioSante Site #221
Berkeley, California, 94705
BioSante Site #127
Billings, Montana, 49101
BioSante Site #124
Bingham Farms, Michigan, 48025
BioSante Site #182
Buena Park, California, 90620
BioSante Site #059
Cary, North Carolina, 27518
BioSante Site #171
Chandler, Arizona, 85224
BioSante Site #003
Charlottesville, Virginia, 22903
BioSante Site #069
Chattanooga, Tennessee, 87404
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 #220
Dallas, Texas, 75231
BioSante Site #147
Dallas, Texas, 75234
BioSante Site #007
Denver, Colorado, 80218
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 #153
Gallipolis, Ohio, 45631
BioSante Site #145
Glendale, Arizona, 85306
BioSante Site #027
Glendale, Arizona, 85308
BioSante Site #047
Grand Rapids, Michigan, 49503
BioSante Site #209
Greer, South Carolina, 29651
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 #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 #105
Kalamazoo, Michigan, 49009
BioSante Site #026
Lakewood, Colorado, 80239
BioSante Site #214
Lexington, Kentucky, 40504
BioSante Site #006
Lincoln, Nebraska, 68510
BioSante Site #155
Little Rock, Arkansas, 72223
BioSante Site #126
Medford, Oregon, 97504
BioSante Site #078
Memphis, Tennessee, 38120
BioSante Site #017
Meridian, Idaho, 83642
BioSante Site #110
Metarie, Louisiana, 70006
BioSante Site #024
Miami, Florida, 33126
BioSante Site #051
Missoula, Montana, 59808
BioSante Site #146
Mobile, Alabama, 36608
BioSante Site #083
Mountlake Terrace, Washington, 98043
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 #167
Newburgh, Indiana, 47630
BioSante Site #086
Norfolk, Virginia, 23502
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 #219
Pinellas Park, Florida, 33781
BioSante Site #144
Pleasant Grove, Utah, 84062
BioSante Site #015
Poughkeepsie, New York, 12601
BioSante Site #107
Raleigh, North Carolina, 27612
BioSante Site #053
Richmond, Virginia, 23294
BioSante Site #036
Ridgefield, Connecticut, 06877
BioSante Site #141
Roswell, Georgia, 30075
BioSante Site #162
Sacramento, California, 95821
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, 78229
BioSante Site #008
San Diego, California, 92108
BioSante Site #128
Seattle, Washington, 98105
BioSante Site #099
Sellersville, Pennsylvania, 18960
BioSante Site #005
Shreveport, Louisiana, 71115
BioSante Site #104
St Louis, Missouri, 63141
BioSante Site #041
St. Petersburg, Florida, 33709
BioSante Site #181
Tacoma, Washington, 98405
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 #049
Watertown, South Dakota, 57201
BioSante Site #138
West Chester, Ohio, 45069
BioSante Site #009
West Palm Beach, Florida, 33409
BioSante Site #197
Wexford, Pennsylvania, 15090
BioSante Site #096
Williston, Vermont, 05495
BioSante Site #131
Winston-Salem, North Carolina, 27103
Canada4 sites
BioSante Site# 123
Ottawa, Ontario, K1H 7W9
BioSante Site #188
Sarnia, Ontario, N7T 4X3
BioSante Site #193
Shawinigan, Quebec, G9N 2H6
BioSante Site #054
Windsor, Ontario, N8W 5L7
About this study
Official title: A Phase III, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Surgically Menopausal Women
The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.
- Conditions
- Hypoactive Sexual Desire Disorder
- Being tested
- transdermal testosterone gel 1%, 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.
transdermal testosterone gel 1%Drug
Also called LibiGel transdermal testosterone gel 1%
300 mcg once daily transdermal testosterone gel 1%
placebo gelDrug
Also called transdermal placebo gel
once daily transdermal placebo gel
| Study group | Role | What they receive |
|---|---|---|
| placebo gel | Placebo comparator | placebo transdermal gel Receives: Drug: placebo gel |
| testosterone gel | Experimental | transdermal testosterone gel Receives: Drug: transdermal testosterone gel 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study
This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
Measured: 12 weeks
Secondary outcomes (2)
change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study
This study is to acess the persistence of benefit following the withdrawal of testosterone gel 1% (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
Measured: 12 weeks
change from baseline (previous study) in the total number of days with at least one satisfying sexual event at weeks 4 and 8 of the current study
This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel)in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionJan 2012
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 626 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235754
- Sponsor's protocol ID
- TESTW009
- Status last verified
- Jan 2013
- First submitted
- 4 Nov 2010
- 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, Multi-Center Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Surgically Menopausal Women
- ClinicalTrials.gov ID
- NCT01235754
- Acronym / sponsor ID
- TESTW009
- Conditions
- Hypoactive Sexual Desire Disorder
- Keywords
- testosterone, hypoactive sexual desire disorder, menopause
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- BioSante PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Nov 2010 (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.
The objective of this study is to evaluate the persistence of benefit of LibiGel (testosterone gel) 300 mcg/day compared to placebo gel in a 12 week post-treatment period of Hypoactive Sexual Desire Disorder (HSDD) in surgically menopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo gel | Placebo comparator | Drug: placebo gelplacebo transdermal gel |
| testosterone gel | Experimental | Drug: transdermal testosterone gel 1%transdermal testosterone gel |
Who may qualify
- Ages
- 30 to 66 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- must have completed a minimum of 22 weeks of the 24-week TESTW006 or TESTW008 clinical trial
Key exclusion criteria (1 listed)
- Any condition (including a change in sexual or relationship history) that would make the subject unsuitable for participation in the trial in the opinion of the Investigator
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 |
|---|---|---|
| transdermal testosterone gel 1%Also: LibiGel transdermal testosterone gel 1%300 mcg once daily transdermal testosterone gel 1% | Drug | testosterone gel |
| placebo gelAlso: transdermal placebo gelonce daily transdermal placebo gel | Drug | placebo gel |
Primary outcome
Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study
Time frame: 12 weeks
This study is to assess the persistence of benefit following the withdrawal of testosterone gel (LibiGel) in the treatment of Hypoactive Sexual Desire Disorder (HSDD) in healthy, surgically menopausal women.
2 secondary outcomes
change from baseline (previous study) in the mean FSDS-R question 13 score to week 12 of the current study
Time frame: 12 weeks
change from baseline (previous study) in the total number of days with at least one satisfying sexual event at weeks 4 and 8 of the current study
Time frame: 12 weeks
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.
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
102 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 transdermal testosterone gel 1% in people with Hypoactive Sexual Desire Disorder, run by BioSante Pharmaceuticals at 102 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 1 inclusion and 1 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 102 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?
Change in the 4-week total number of days with at least one satisfying sexual event from the baseline period (during the previous study) to weeks 9-12 of the current study (time frame: 12 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.