HypogonadismPhase 2NCT00398580
28-Day Study of Testosterone Co-administered With Dutasteride in Hypogonadal Men
A Phase 2 study testing Nanomilled testosterone, Nanomilled dutasteride and commercially available dutasteride in people with Hypogonadism and Hypogonadism, Male, run by GlaxoSmithKline at 7 sites in United States.
Trial summary
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Hypogonadism, Hypogonadism, Male
- What is being tested?
- Nanomilled testosterone, Nanomilled dutasteride and commercially available dutasteride
- How many people
- 43 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2006to Oct 2007
- Phase
- Phase 2
- 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 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of primary or secondary hypogonadism.
- Have very low testosterone levels on 2 separate days.
- Have a BMI within range of 18.5-35kg/m2.
- Have not taken dutasteride for one year, or finasteride for the past 3 months.
Who cannot join
- Have had or have breast or prostate cancer, malabsorption syndrome, sleep apnea, psychiatric illness, polycythemia, or any other clinically significant current condition.
- Are diabetic with an HbA1c >= 8.
- Are taking any androgens, such as testosterone, saw palmetto.
- Are taking ritonavir, indinavir, itraconazole, ketoconazole, erythromycin, warfarin, digoxin, cholestyramine, or any dietary/herbal/vitamin supplements.
- 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 EKG abnormality.
- 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
7 sites in 1 country.
7 sites in 1 country
United States7 sites
GSK Investigational Site
Baltimore, Maryland, 21287
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Seattle, Washington, 98108
GSK Investigational Site
Seattle, Washington, 98195
GSK Investigational Site
Torrance, California, 90502
About this study
Official title: A Phase II, 28-Day, Randomized, Parallel-Group, Open-Label Study Evaluating the Efficacy and Safety of Twice Daily Oral Doses of Testosterone (150-400mg) Co-administered With 0.25mg Dutasteride Compared With 400mg Testosterone Alone and 0.25mg Dutasteride Alone in the Treatment of Hypogonadism
The combination of testosterone and dutasteride is intended for use in hypogonadal men. This study will evaluate the effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.
- Conditions
- Hypogonadism, Hypogonadism, Male
- Being tested
- Nanomilled testosterone, Nanomilled dutasteride, commercially available dutasteride
- Keywords
- DHT, Testosterone, Hypogonadism, Dutasteride, Androgen deficiency
- Medical subject headings
- Hypogonadism, Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanomilled testosteroneDrug
Nanomilled dutasterideDrug
commercially available dutasterideDrug
Also called Nanomilled testosterone, Nanomilled dutasteride
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine
Measured: days 1 and 28
Secondary outcomes (3)
Testosterone concentration .
Measured: on days 1 and 28
Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride
Measured: days 1 and 28.
Anabolic & androgenic Pharmacodynamic biomarkers
Measured: pre- and post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2007
- Study completionOct 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, M.D., Ph.D., FACP, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398580
- Sponsor's protocol ID
- TDC106220
- Status last verified
- May 2017
- First submitted
- 8 Nov 2006
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, 28-Day, Randomized, Parallel-Group, Open-Label Study Evaluating the Efficacy and Safety of Twice Daily Oral Doses of Testosterone (150-400mg) Co-administered With 0.25mg Dutasteride Compared With 400mg Testosterone Alone and 0.25mg Dutasteride Alone in the Treatment of Hypogonadism
- ClinicalTrials.gov ID
- NCT00398580
- Acronym / sponsor ID
- TDC106220
- Conditions
- Hypogonadism, Hypogonadism, Male
- Keywords
- DHT, Testosterone, Hypogonadism, Dutasteride, Androgen deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 10 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 effect of 28-day repeat dosing of this combination with varying BID doses of testosterone (T), in combination with a fixed BID dose of dutasteride (D), as well as a testosterone alone arm, on T and D levels in the blood. The rationale is to look for the effects of each compound on the other, and to look for any safety problems that may result when the 2 drugs are given together.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a diagnosis of primary or secondary hypogonadism.
- Have very low testosterone levels on 2 separate days.
- Have a BMI within range of 18.5-35kg/m2.
- Have not taken dutasteride for one year, or finasteride for the past 3 months.
Key exclusion criteria (12 listed)
- Have had or have breast or prostate cancer, malabsorption syndrome, sleep apnea, psychiatric illness, polycythemia, or any other clinically significant current condition.
- Are diabetic with an HbA1c >= 8.
- Are taking any androgens, such as testosterone, saw palmetto.
- Are taking ritonavir, indinavir, itraconazole, ketoconazole, erythromycin, warfarin, digoxin, cholestyramine, or any dietary/herbal/vitamin supplements.
- Would donate more than 500 ML of blood over a 2 month period.
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 | – |
| Nanomilled dutasteride | Drug | – |
| commercially available dutasterideAlso: Nanomilled testosterone, Nanomilled dutasteride | Drug | – |
Primary outcome
Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine
Time frame: days 1 and 28
3 secondary outcomes
Testosterone concentration .
Time frame: on days 1 and 28
Pharmacokinetics of testosterone, DHT, estradiol, estrone & dutasteride
Time frame: days 1 and 28.
Anabolic & androgenic Pharmacodynamic biomarkers
Time frame: pre- and post-dose
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 30 May 2017.
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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, M.D., Ph.D., FACP study director
GlaxoSmithKline
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nanomilled testosterone, Nanomilled dutasteride and commercially available dutasteride in people with Hypogonadism and Hypogonadism, Male, run by GlaxoSmithKline at 7 sites 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety measured by: monitoring laboratory tests changes in blood pressure and heart rate and heart activity on an ECG machine (time frame: days 1 and 28). 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 30 May 2017.