Trial · NCT00957528
Cycled Testosterone Replacement Study
NCT00957528, Phase 1, Completed, The University of Texas Medical Branch, Galveston; results first posted 2012-08-21
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Cycled Testosterone Replacement Study. Trials, record NCT00957528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00957528
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cycled Testosterone Replacement Study
- NCT number
- NCT00957528
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 26 participants, actual
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Conditions
- Hypogonadism
- Interventions
- Testosterone, Placebo
- First posted
- 2009-08-12
- Last updated
- 2012-09-10
- Results first posted
- 2012-08-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | 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. |
| Primary | 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 | 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). |
| Primary | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | 5 months | Lean body mass is expressed in grams as calculated by Hologic DEXA. |
| Secondary | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | 5 months | Bone mineral density measure by measured by dual energy x-ray absorptiometry (DEXA)measured at baseline and a five months |
| Secondary | Changes in Serum Markers of Bone Turnover. | 5 months | 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 |
| Secondary | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | 5 months | 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 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | 5 Months | Subjects who completed the entire treatment protocol | Percent per hour (%/hr) | MEAN |
| PRIMARY | 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 | 5 months | pounds | MEAN | |
| PRIMARY | Changes in Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) | 5 months | All subjects who successfully completed the five month protocol. | grams | MEAN |
| SECONDARY | Changes in Bone Mineral Density as Measured by Dual Energy X-ray Absorptiometry (DEXA) | 5 months | gm/cm^2 | MEAN | |
| SECONDARY | Changes in Serum Markers of Bone Turnover. | 5 months | nM BCE (Bone Collagen Equivalents) | MEAN | |
| SECONDARY | 9473Changes in Serum Inflammatory Biomarkers and Muscle Inflammatory Cytokines | 5 months | All subjects who completed the protocol. | pg/mL | MEAN |
Source ClinicalTrials.gov
Results by group228
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | Placebo | Baseline | 0.05 | Standard Deviation 0.01 | Percent per hour (%/hr) |
| Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | Monthly Cycled Testosterone | Baseline | 0.06 | Standard Deviation 0.01 | Percent per hour (%/hr) |
| Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | Continuous Testosterone | Baseline | 0.06 | Standard Deviation 0.01 | Percent per hour (%/hr) |
| Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | Placebo | Five Months | 0.066 | Standard Deviation 0.020 | Percent per hour (%/hr) |
| Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | Monthly Cycled Testosterone | Five Months | 0.094 | Standard Deviation 0.014 | Percent per hour (%/hr) |
| Changes in Basal Muscle Protein Synthesis and Breakdown as Measured by Stable Isotope Metabolic Studies at Baseline and at Five Months | Continuous Testosterone | Five Months | 0.101 | Standard Deviation 0.043 | Percent per hour (%/hr) |
| 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 | Placebo | Arm Curl Baseline | 39 | Standard Deviation 12 | pounds |
| 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 | Monthly Cycled Testosterone | Arm Curl Baseline | 39 | Standard Deviation 10 | pounds |
| 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 | Continuous Testosterone | Arm Curl Baseline | 32 | Standard Deviation 9 | pounds |
| 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 | Placebo | Arm Extension Baseline | 40 | Standard Deviation 9 | pounds |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | STARTED | Monthly Cycled Testosterone | 9 | |
| Overall Study | STARTED | Continuous Testosterone | 9 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | COMPLETED | Monthly Cycled Testosterone | 8 | |
| Overall Study | COMPLETED | Continuous Testosterone | 8 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Monthly Cycled Testosterone | 1 | |
| Overall Study | NOT COMPLETED | Continuous Testosterone | 1 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Saphenous vein clot | Vascular disorders | Placebo | 1 | 8 | |
| other | Saphenous vein clot | Vascular disorders | Monthly Cycled Testosterone | 0 | 8 | |
| other | Saphenous vein clot | Vascular disorders | Continuous Testosterone | 1 | 8 | |
| other | vertigo | Nervous system disorders | Placebo | 1 | 8 | |
| other | vertigo | Nervous system disorders | Monthly Cycled Testosterone | 0 | 8 | |
| other | vertigo | Nervous system disorders | Continuous Testosterone | 1 | 8 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Monthly Cycled Testosterone | ||
| Total, all-cause mortality | Continuous Testosterone | ||
| Total, other adverse events | Placebo | 1 | 8 |
| Total, other adverse events | Monthly Cycled Testosterone | 0 | 8 |
| Total, other adverse events | Continuous Testosterone | 1 | 8 |
| Total, serious adverse events | Placebo | 0 | 8 |
| Total, serious adverse events | Monthly Cycled Testosterone | 0 | 8 |
| Total, serious adverse events | Continuous Testosterone | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01AG022023 | Cyclic Testosterone on muscle function in older men | URBAN, RANDALL J | UNIVERSITY OF TEXAS MED BR GALVESTON | NATIONAL INSTITUTE ON AGING | 2004 to 2009 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00957528
GET https://conductscience.org/api/trials/v1/NCT00957528/results?page=2