HypogonadismPhase 1NCT00400335
Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride
A Phase 1 study testing Nanomilled testosterone, commercially available dutasteride and Nanomilled dutasteride in people with Hypogonadism and Hypogonadism, Male, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Hypogonadism, Male
- What is being tested?
- Nanomilled testosterone, commercially available dutasteride and Nanomilled dutasteride
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to not given
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are healthy.
- Have a BMI within range of 19-32 kg/m2.
- Have not taken dutasteride for one year, or finasteride for the past 3 months.
- Have a screening PSA < 2.0ng/mL.
Who cannot join
- Have had or have breast or prostate cancer, sleep apnea, psychiatric illness, or any other clinically significant current condition.
- Have a trigliceride level =500mg/dL.
- Have abnormal thyroid or hormone levels.
- Would donate more than 500 ML of blood over a 2 month period.
- Physician does not think it is a good idea for you to participate in the trial.
- Are unwilling to abstain from alcohol during the study.
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- Have a positive urine drug screen test.
- Plan to change your smoking habits during the course of the trial.
- Have Hepatitis C, Hepatitis B, or HIV.
- Have a lab or ECG abnormality.
- Have high or low blood pressure.
- Have used of any investigational drug or device during the study or within 30 days prior to 1st dosing of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study to Evaluate the Impact of Novel Fixed-dose Testosterone/Dutasteride Combinations on the Relative Bioavailability of the Individual Dutasteride and Testosterone Components
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride
- Conditions
- Hypogonadism, Hypogonadism, Male
- Being tested
- Nanomilled testosterone, commercially available dutasteride, Nanomilled dutasteride
- Keywords
- Testosterone, Men, Hypogonadism, Dutasteride, DHT, Androgen deficiency
- Medical subject headings
- Hypogonadism, Eunuchism, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanomilled testosteroneDrug
commercially available dutasterideDrug
Nanomilled dutasterideDrug
Also called commercially available dutasteride, Nanomilled testosterone
What is being measured
The primary outcome is the main question the study is designed to answer.
lab tests for relative bioavailability of testosterone and dutasteride,
Measured: days 1, 2, 3, 19, 20, 21 & 26-31
Secondary outcomes (2)
safety lab tests of various testosterone/dutasteride formulations,
Measured: days 1, 2, 3, 19, 20, 21 & 26-31.
lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,
Measured: days 1, 2, 3, 19, 20, 21 & 26-31.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400335
- Sponsor's protocol ID
- TDC106222
- Status last verified
- Feb 2011
- First submitted
- 14 Nov 2006
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Impact of Novel Fixed-dose Testosterone/Dutasteride Combinations on the Relative Bioavailability of the Individual Dutasteride and Testosterone Components
- ClinicalTrials.gov ID
- NCT00400335
- Acronym / sponsor ID
- TDC106222
- Conditions
- Hypogonadism, Hypogonadism, Male
- Keywords
- Testosterone, Men, Hypogonadism, Dutasteride, DHT, Androgen deficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- First posted
- 16 Nov 2006 (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 combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the bioavailability and pharmacokinetics of various doses of testosterone administered with and without dutasteride
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Are healthy.
- Have a BMI within range of 19-32 kg/m2.
- Have not taken dutasteride for one year, or finasteride for the past 3 months.
- Have a screening PSA < 2.0ng/mL.
Key exclusion criteria (12 listed)
- Have had or have breast or prostate cancer, sleep apnea, psychiatric illness, or any other clinically significant current condition.
- Have a trigliceride level =500mg/dL.
- Have abnormal thyroid or hormone levels.
- Would donate more than 500 ML of blood over a 2 month period.
- Physician does not think it is a good idea for you to participate in the trial.
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 |
|---|---|---|
| Nanomilled testosterone | Drug | – |
| commercially available dutasteride | Drug | – |
| Nanomilled dutasterideAlso: commercially available dutasteride, Nanomilled testosterone | Drug | – |
Primary outcome
lab tests for relative bioavailability of testosterone and dutasteride,
Time frame: days 1, 2, 3, 19, 20, 21 & 26-31
2 secondary outcomes
safety lab tests of various testosterone/dutasteride formulations,
Time frame: days 1, 2, 3, 19, 20, 21 & 26-31.
lab tests for additional pharmacokinetic parameters for testosterone & dutasteride,
Time frame: days 1, 2, 3, 19, 20, 21 & 26-31.
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 4 Jun 2012.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nanomilled testosterone, commercially available dutasteride and Nanomilled dutasteride in people with Hypogonadism and Hypogonadism, Male, run by GlaxoSmithKline at 1 site in United States.
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 4 inclusion and 12 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 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
lab tests for relative bioavailability of testosterone and dutasteride, (time frame: days 1, 2, 3, 19, 20, 21 & 26-31). 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 4 Jun 2012.