HypogonadismPhase 1NCT01133548
Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males
A Phase 1 study testing Testosterone Gel 1.62% in people with Hypogonadism, run by AbbVie.
Trial summary
To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites. 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 Gel 1.62%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Jul 2010
- Phase
- Phase 1
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypogonadal males
- Screening testosterone <300 ng/dL
Who cannot join
- Smokers
- Previous history of or current or suspected prostate or breast cancer
About this study
Official title: A Multiple Dose Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of 5 g Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males
To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
Read the detailed description
To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
- Conditions
- Hypogonadism
- Being tested
- Testosterone Gel 1.62%
- Keywords
- testosterone, hypogonadal, males
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone Gel 1.62%Drug
5 grams administered using an application Site Rotation
Testosterone Gel 1.62%Drug
5 grams administered using an a combination of Application sites
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Testosterone Gel 1.62% Receives: Drug: Testosterone Gel 1.62% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration observed (Cmax)
Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol
Measured: Up to 24 days
Area Under the Plasma Concentration-time Curve (AUC)
Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol
Measured: Up to 24 days
Time of Cmax (Tmax)
Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol
Measured: Up to 24 days
Average Plasma Concentration observed (Cav)
Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol
Measured: Up to 24 days
Secondary outcomes (2)
Application site evaluation based on the clinical evaluation of skin reactions grading scale
Measured: 24 days
Adverse events
Measured: 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael miller, PharmD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133548
- Sponsor's protocol ID
- S176.1.010
- Status last verified
- Jun 2011
- First submitted
- 21 May 2010
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaufman JM, Miller MG, Garwin JL, Fitzpatrick S, McWhirter C, Brennan JJ. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med. 2011 Jul;8(7):2079-89. doi: 10.1111/j.1743-6109.2011.02265.x. Epub 2011 Apr 14.
PubMed 21492400
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Pharmacokinetic and Comparative Bioavailability Study of Testosterone Absorption After Administration of 5 g Testosterone Gel 1.62% to the Upper Arms/Shoulders Using an Application Site Rotation or a Combination of Application Sites in Hypogonadal Males
- ClinicalTrials.gov ID
- NCT01133548
- Acronym / sponsor ID
- S176.1.010
- Conditions
- Hypogonadism
- Keywords
- testosterone, hypogonadal, males
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 31 May 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.
To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
Detailed description
To evaluate the pharmacokinetics and comparative bioavailability of Testosterone absorption in 36 Hypogonadal males after administration of 5 g Testosterone Gel 1.62% to the upper arms/shoulders using an application site rotation or a combination of application sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Testosterone Gel 1.62%Testosterone 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 (2 listed)
- Hypogonadal males
- Screening testosterone <300 ng/dL
Key exclusion criteria (2 listed)
- Smokers
- Previous history of or current or suspected prostate or breast cancer
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 Gel 1.62%5 grams administered using an application Site Rotation | Drug | 1 |
| Testosterone Gel 1.62%5 grams administered using an a combination of Application sites | Drug | 1 |
Primary outcome
Maximum Plasma Concentration observed (Cmax)
Time frame: Up to 24 days
Maximum plasma concentration observed (Cmax) of total testosterone, dihydrotestosterone, estradiol
Area Under the Plasma Concentration-time Curve (AUC)
Time frame: Up to 24 days
Area under the plasma concentration-time curve (AUC) of total testosterone, dihydrotestosterone, estradiol
Time of Cmax (Tmax)
Time frame: Up to 24 days
Time of Cmax (Tmax) of total testosterone, dihydrotestosterone, estradiol
Average Plasma Concentration observed (Cav)
Time frame: Up to 24 days
Average plasma concentration observed (Cav) of total testosterone, dihydrotestosterone, estradiol
2 secondary outcomes
Application site evaluation based on the clinical evaluation of skin reactions grading scale
Time frame: 24 days
Adverse events
Time frame: 24 days
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 7 Dec 2017.
- Results publication: PubMed 21492400Kaufman JM, Miller MG, Garwin JL, Fitzpatrick S, McWhirter C, Brennan JJ. Efficacy and safety study of 1.62% testosterone gel for the treatment of hypogonadal men. J Sex Med. 2011 Jul;8(7):2079-89. doi: 10.1111/j.1743-6109.2011.02265.x. Epub 2011 Apr 14.
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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 miller, PharmD study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Testosterone Gel 1.62% in people with Hypogonadism, run by AbbVie.
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 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 7 Dec 2017. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum Plasma Concentration observed (Cmax) (time frame: Up to 24 days). The study lists 4 primary outcomes in all. 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 NCT01133548, 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 7 Dec 2017.