HypogonadismPhase 1NCT00957528
Cycled Testosterone Replacement Study
A Phase 1 study testing Testosterone in people with Hypogonadism, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years. Read more about this study
- Who is it for?
- Ages 60 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testosterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2008
- Phase
- Phase 1
- 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 60 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Availability of transportation (i.e., subjects must be able to provide their own transportation to UTMB).
Who cannot join
- Medications such as anticoagulants (Coumadin) and glucocorticoids.
- History of angina that occurs with exertion or at rest.
- History of myocardial infarction within the last 12 months.
- Failure to successfully complete an exercise stress test using the Bruce protocol. Subjects that demonstrate ≥ 0.1 mV horizontal or downsloping ST segment depression, a drop in systolic blood pressure of ≥ 10 mm Hg, and/or frequent or repetitive arrhythmias (defined as ≥ 10 PVC/min, or couplets) during the stress test will be excluded.
- LDL cholesterol above 200 mg/dL.
- History of prostatic cancer.
Show all 18Show fewer
- Elevated prostate specific antigen (PSA) above 4.0 µg/L, or severe benign prostatic hypertrophy (BPH) by history (frequent urination, reduced stream).
- Serum total testosterone concentrations of greater than 500 ng/dL.
- Subjects who engage in high intensity, elite training on a regular basis.
- Major medical illness such as diabetes, chronic obstructive pulmonary disease, or sleep apnea.
- Recent history of smoking tobacco.
- Hematocrit greater than 51%.
- Morbidly obese older men (BMI > 35).
- Hypertension: Blood pressure on three consecutive measurements taken at one week intervals that has a systolic pressure ≥ 140 or a diastolic blood pressure ≥ 90. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria.
- History of hepatitis or a 3-fold elevation of liver function tests (Alk phos, ALT, AST).
- Bone related disorders such as osteoporosis or parathyroid disease.
- DEXA scans revealing lumbar spine T-scores of less than -2.5.
- Subjects currently taking anti-bone-resorptive agents such as bisphosphonates, parathyroid hormone, or calcitonin.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: The Effects of Cyclic Testosterone Administration on Muscle Function in Older Individuals
The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body composition, muscle metabolism, muscle strength, and bone metabolism.
Read the detailed description
Men and women undergo a progressive reduction in lean muscle mass (sarcopenia) with advancing age regardless of their level of physical activity. A 12-yr longitudinal study in healthy sedentary older men showed a correlation between loss of muscle cross-sectional area and muscle strength of the thigh, quadriceps, and flexor muscles. Once weakened, older individuals are prone to falls that prevent independent living and diminish the quality of life. There is a need to develop therapies to counteract losses in skeletal muscle strength with aging. Studies show that exercise and testosterone administration increase skeletal muscle mass and strength in older men. However, the increase in muscle strength by testosterone in older men has not been consistent in all studies. Androgens increase muscle mass by either increasing muscle protein synthesis or inhibiting muscle protein breakdown. This proposal will investigate the hypothesis that cyclic testosterone administration (monthly on/off cycles) will preferentially increase muscle protein synthesis and result in a consistent and greater improvement in muscle strength than continuous testosterone administration.
- Conditions
- Hypogonadism
- Being tested
- Testosterone, Placebo
- Keywords
- Low Normal Testosterone, Male, Aging
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Also called Testosterone Enanthate
Weekly im injections of 100 mg testosterone enanthate.
PlaceboDrug
Also called Sesame Oil
Weekly IM injections of sesame oil.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Weekly placebo treatment for a duration of 5 months. Receives: Drug: Placebo |
| Monthly Cycled Testosterone | Experimental | A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months. Receives: Drug: Testosterone; Drug: Placebo |
| Continuous Testosterone | Experimental | Weekly testosterone treatment for a duration of 5 months Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months
The fractional synthetic rate (FSR) of mixed muscle is calculated by directly measuring the incorporation of L-[ring-13C6]-phenylalanine into protein (%/hr),, using the precursor-product model: FSR = [(EP2 - EP1)/(EM•t)]•60•100, where EP1 and EP2 are the enrichments of bound L-[ring-13C6]-phenylalanine in the first and second muscle biopsies, t is the time interval (min) between biopsies, and EM is the mean L-[ring-13C6]-phenylalanine enrichment in the muscle intracellular pool.
Measured: 5 Months
Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months
Maximum weight (pounds) lifted using Cybex weight machine in a single effort(1-RM) for upper extremities (biceps and triceps) and lower extremities quadriceps and hamstrings).
Measured: 5 months
Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)
Lean body mass is expressed in grams as calculated by Hologic DEXA.
Measured: 5 months
Secondary outcomes (3)
Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA)
Bone mineral density measure by measured by dual energy x-ray absorptiometry (DEXA)measured at baseline and a five months
Measured: 5 months
Changes in Serum Markers of Bone Turnover.
Measures of bone turnover markers in serum samples at baseline and at five months.The bone turnover markers analyzed include:
Markers associated with bone breakdown NTX (N-telopeptide) TRAP5b (tartrate-resistant acid phosphatase isoform 5b) Markers associated with bone formation Osteocalcin BAP (bone specific alkaline phosphatase) Regulators of bone formation iPTH (intact parathyroid hormone) increases in response to bone loss Calcitonin inhibits bone formation in response to elevated levels of serum calcium
Measured: 5 months
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
Serum inflammatory biomarkers (Interleukin B-1, 2,5,6,7,8,10,12 13, Interferon gamma, GM-CSF, and Tumor Necrosis Factor alpha)as measured by immunoassay at baseline and at five months
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startJan 2006
- Primary completionDec 2008
- Study completionDec 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.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randall J Urban, M.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957528
- Sponsor's protocol ID
- 01-302
- Other IDs
- GCRC 615, R01AG022023
- Status last verified
- Sep 2012
- First submitted
- 10 Aug 2009
- Last updated
- 10 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cyclic Testosterone Administration on Muscle Function in Older Individuals
- ClinicalTrials.gov ID
- NCT00957528
- Acronym / sponsor ID
- 01-302
- Conditions
- Hypogonadism
- Keywords
- Low Normal Testosterone, Male, Aging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Posted 21 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether testosterone (male hormone) therapy is effective if administered in a cyclic fashion (periodic dosing) compared to continuous dosing in men aged 60 to 85 years. Effectiveness will be determined based on improvements in body composition, muscle metabolism, muscle strength, and bone metabolism.
Detailed description
Men and women undergo a progressive reduction in lean muscle mass (sarcopenia) with advancing age regardless of their level of physical activity. A 12-yr longitudinal study in healthy sedentary older men showed a correlation between loss of muscle cross-sectional area and muscle strength of the thigh, quadriceps, and flexor muscles. Once weakened, older individuals are prone to falls that prevent independent living and diminish the quality of life. There is a need to develop therapies to counteract losses in skeletal muscle strength with aging. Studies show that exercise and testosterone administration increase skeletal muscle mass and strength in older men. However, the increase in muscle strength by testosterone in older men has not been consistent in all studies. Androgens increase muscle mass by either increasing muscle protein synthesis or inhibiting muscle protein breakdown. This proposal will investigate the hypothesis that cyclic testosterone administration (monthly on/off cycles) will preferentially increase muscle protein synthesis and result in a consistent and greater improvement in muscle strength than continuous testosterone administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboWeekly placebo treatment for a duration of 5 months. |
| Monthly Cycled Testosterone | Experimental | Drug: Testosterone, Drug: PlaceboA month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months. |
| Continuous Testosterone | Experimental | Drug: TestosteroneWeekly testosterone treatment for a duration of 5 months |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Availability of transportation (i.e., subjects must be able to provide their own transportation to UTMB).
Key exclusion criteria (18 listed)
- Medications such as anticoagulants (Coumadin) and glucocorticoids.
- History of angina that occurs with exertion or at rest.
- History of myocardial infarction within the last 12 months.
- Failure to successfully complete an exercise stress test using the Bruce protocol. Subjects that demonstrate ≥ 0.1 mV horizontal or downsloping ST segment depression, a drop in systolic blood pressure of ≥ 10 mm Hg, and/or frequent or repetitive arrhythmias (defined as ≥ 10 PVC/min, or couplets) during the stress test will be excluded.
- LDL cholesterol above 200 mg/dL.
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 |
|---|---|---|
| TestosteroneAlso: Testosterone EnanthateWeekly im injections of 100 mg testosterone enanthate. | Drug | Continuous Testosterone, Monthly Cycled Testosterone |
| PlaceboAlso: Sesame OilWeekly IM injections of sesame oil. | Drug | Monthly Cycled Testosterone, Placebo |
Primary outcome
Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months
Time frame: 5 Months
The fractional synthetic rate (FSR) of mixed muscle is calculated by directly measuring the incorporation of L-[ring-13C6]-phenylalanine into protein (%/hr),, using the precursor-product model: FSR = [(EP2 - EP1)/(EM•t)]•60•100, where EP1 and EP2 are the enrichments of bound L-[ring-13C6]-phenylalanine in the first and second muscle biopsies, t is the time interval (min) between biopsies, and EM is the mean L-[ring-13C6]-phenylalanine enrichment in the muscle intracellular pool.
Changes in Muscle Strength as Measured by Maximal Voluntary Contraction Tests (Arm Curl) at Baseline, One Month, Two Months, Three Months, Four Months, and at Five Months
Time frame: 5 months
Maximum weight (pounds) lifted using Cybex weight machine in a single effort(1-RM) for upper extremities (biceps and triceps) and lower extremities quadriceps and hamstrings).
Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA)
Time frame: 5 months
Lean body mass is expressed in grams as calculated by Hologic DEXA.
3 secondary outcomes
Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA)
Time frame: 5 months
Changes in Serum Markers of Bone Turnover.
Time frame: 5 months
9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines
Time frame: 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Randall J Urban, M.D. principal investigator
University of Texas
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 Testosterone in people with Hypogonadism, run by The University of Texas Medical Branch, Galveston 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 1 inclusion and 18 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 Sep 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. 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 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?
Yes. Results are posted in the registry (first posted 21 Aug 2012). 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?
Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months (time frame: 5 Months). The study lists 3 primary outcomes in all. 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 Sep 2012.