HypogonadismPhase 3NCT00433199

Testosterone Treatment for Hypogonadal Men

A Phase 3 study testing Testosterone (T) Gel 1.62% in people with Hypogonadism, run by Abbott.

Completed

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

Trial summary

Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men Read more about this study

Who is it for?: Ages 18 to 80 years, men only
Conditions the study is for: Hypogonadism
What is being tested?: Testosterone (T) Gel 1.62%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 274 participants
Where: No sites listed yet
Study dates: Feb 2007to Apr 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Low T males 18 - 80 years of age

Who cannot join

Normal T levels
Elevated Prostatic Specific Antigen (PSA)

About this study

Official title: A Multi-Center, Randomized, Double-Blind,Placebo-Controlled Efficacy and Safety Study of Testosterone Gel 1.62% for the Treatment of Hypogonadal Men

Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men

Conditions: Hypogonadism
Being tested: Testosterone (T) Gel 1.62%, Placebo
Keywords: Hypogonadism, Testosterone Deficiency
Medical subject headings: Hypogonadism

What participants receive

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

Testosterone (T) Gel 1.62%Drug
Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.
PlaceboDrug
Placebo Control

Study groups in NCT00433199
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo
T-Gel 1.62%	Experimental	Testosterone (T) gel 1.62% Receives: Drug: Testosterone (T) Gel 1.62%

What is being measured

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

Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112
Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results
Measured: Day 112

Secondary outcomes (5)

Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14
Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 14. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 14 PK results
Measured: Day 14
Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56
Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 56. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 56 PK results
Measured: Day 56
Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182
Cav results were required to fall within the normal range of 300-1000 ng/dL at Day 182. Success was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 182 PK results.
Measured: Day 182
Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.
The success at Day 266 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
Measured: Day 266
Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.
The success at Day 364 was defined as >=75% of subjects within the normal serum total testosterone concentration range of 300-1000 ng/dL. The Lower bounds of the 95% CI was to be not less than 65%.
Measured: Day 364

Timeline

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

Feb 2007Apr 2008

First posted9 Feb 2007 (estimated)
Study startFeb 2007
Primary completionOct 2007
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HypogonadismStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 274 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00433199
Sponsor's protocol ID: S176.3.104
Status last verified: Nov 2011
First submitted: 8 Feb 2007
Last updated: 27 Jan 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Kaufman JM, Miller MG, Fitzpatrick S, McWhirter C, Brennan JJ. One-year efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: results of a 182-day open-label extension of a 6-month double-blind study. J Sex Med. 2012 Apr;9(4):1149-61. doi: 10.1111/j.1743-6109.2011.02630.x. Epub 2012 Feb 9.
PubMed 22321357

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism
Male Hypogonadism
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
RecruitingPhase 2
Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients
Hypogonadism, Prostate Cancer
Not yet recruitingPhase 2
A Dose Ranging Study to Examine TDS-Testosterone 5%
Hypogonadotropism

All Hypogonadism trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Double-Blind,Placebo-Controlled Efficacy and Safety Study of Testosterone Gel 1.62% for the Treatment of Hypogonadal Men
ClinicalTrials.gov ID: NCT00433199
Acronym / sponsor ID: S176.3.104
Conditions: Hypogonadism
Keywords: Hypogonadism, Testosterone Deficiency
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 274 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Oct 2007 (actual)
Study completion: Apr 2008 (actual)
First posted: 9 Feb 2007 (estimated)
Results: Posted 8 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo
T-Gel 1.62%	Experimental	Drug: Testosterone (T) Gel 1.62%Testosterone (T) gel 1.62%

Who may qualify

Ages: 18 to 80 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Low T males 18 - 80 years of age

Key exclusion criteria (2 listed)

Normal T levels
Elevated Prostatic Specific Antigen (PSA)

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 (T) Gel 1.62%Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.	Drug	T-Gel 1.62%
PlaceboPlacebo Control	Drug	Placebo

Primary outcome

Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112
Time frame: Day 112
Cav results were required to fall within the normal range of 300-1000 ng/dL. Success in the study was defined as >=75% of subjects on active treatment within the normal serum testosterone concentration range of 300-1000 ng/dL. In addition, the lower bound of the 95% CI was to be not less than 65% based on the Day 112 Parmacokinetics (PK) results

5 secondary outcomes

Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 14
Time frame: Day 14
Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 56
Time frame: Day 56
Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 182
Time frame: Day 182
Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 266.
Time frame: Day 266
Percentage of Subjects Achieving Target Range for Testosterone Cav During the Open-label Period at Day 364.
Time frame: Day 364

Results and safety

Results posted to the registry on 8 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	40	28
T-Gel 1.62%	234	168

Primary outcome: Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112

Time frame: Day 112. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	T-Gel 1.62% n = 179	Placebo n = 27
Value	81.6 (75.1 to 87.0)	37.0 (19.4 to 57.6)

Population analysed: The analysis was done on the Full analysis sample defined as the subjects who were included in the Safety Sample and who had data for at least one post-Baseline assessment of any efficacy measurement up to and including Day 182 (double-blind period). The number correspond to the number of subjects having a measurement at Day 112;

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events presented were collected from start of drug treatment to the end of the double-blind treatment period (from Day 0 to Day 182).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 40 (2.5%)	5 of 40 (12.5%)	Not reported
T-Gel 1.62%	5 of 234 (2.1%)	47 of 234 (20.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22321357Kaufman JM, Miller MG, Fitzpatrick S, McWhirter C, Brennan JJ. One-year efficacy and safety study of a 1.62% testosterone gel in hypogonadal men: results of a 182-day open-label extension of a 6-month double-blind study. J Sex Med. 2012 Apr;9(4):1149-61. doi: 10.1111/j.1743-6109.2011.02630.x. Epub 2012 Feb 9.

Related trials for Hypogonadism

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 3
Safety and Efficacy of Weekly Testosterone Cypionate Auto-Injector in Men With Hypogonadism
Male Hypogonadism
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
RecruitingPhase 2
Clinical Trial to Observe the Effects of Tamoxifen on Testosterone Recovery in Medically Castrated Prostate Cancer Patients
Hypogonadism, Prostate Cancer
Not yet recruitingPhase 2
A Dose Ranging Study to Examine TDS-Testosterone 5%
Hypogonadotropism

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.

Global Clinical Director Solvay study director

Abbott Products

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Testosterone (T) Gel 1.62% in people with Hypogonadism, run by Abbott.

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 2 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 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 8 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Subjects on Testosterone Treatment Achieving Target Range for Testosterone Cav (Time-averaged Concentration Over the Dosing Interval of 24 Hours) on Day 112 (time frame: Day 112). 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 NCT00433199, 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 27 Jan 2015; AzTrials last refreshed its copy on 30 Oct 2026.