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Skeletal muscle loss is a common consequence of aging and in some individuals reaches a level that compromises health and quality of life. Age-associated increases in cytokine and inflammatory signaling may be important contributors to this process.
The investigators will assess the practical question of whether testosterone injection and gel application elicit similar responses. Resistance exercise will be used as a means of stimulating both inflammatory and anabolic responses in skeletal muscle. In order to assess the effects of testosterone on these responses, subjects will perform resistance exercise on two occasions separated by 7 days. The first session will be performed prior to the initiation of testosterone and/or medrol therapy and the second session will be performed after receiving therapy for 7 days.
4 groups of healthy men aged 60 - 85 years were studied over 15 days, in 2 distinct time periods, pre-treatment and treatment.
Pre treatment week from study day -7 to study day -1. Treatment week from study day 1 to study day 8.
Groups:
Subjects were asked to fill out the Brief Fatigue Inventory daily for all 15 days.
Subjects were studied at the clinical research center before treatment (study day 1) and after treatment (study day 8). Resistance exercise was performed on study days 1 and 8. Blood was drawn before and after exercise for measurement of serum cortisol. Subjects were asked to return to the clinical research center each day during the treatment week (study days 1-8) for blood draws for measurement of total testosterone, estradiol and C-reactive protein (CRP). Labs were drawn on study days 1 and 8 for complete blood count, comprehensive metabolic panel and lipid panel.
Part 1:
In this part of the project we will study the acute response to testosterone treatment between two groups of subjects, comparing two methods of administration (injection vs. topical gel) in order to obtain pilot information for a subsequent, randomized, blinded long-term investigation.
Part 2:
In this part of the project we will study the acute response to Medrol (methylprednisolone) taken over 7 days with or without testosterone (given as 100mg IM) in order to obtain pilot information for a subsequent, randomized, blinded long-term investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone injection | Active Comparator | Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection |
|
| Testosterone gel | Active Comparator | Testosterone topical gel (Androgel 1%) 10 mg administered daily for seven days |
|
| Testosterone injection and Medrol 6 day dose pack | Active Comparator | Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. |
|
| Medrol 6 day dose pack | Active Comparator | Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone injection | Drug | 100 mg single IM injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study) | Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | treatment day 1 |
| Serum Total Testosterone Measured on Treatment Day 2 | Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | treatment day 2 |
| Serum Total Testosterone Measured on Treatment Day 3 | TTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | treatment day 3 |
| Serum Total Testosterone Measured on Treatment Day 4 | Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | treatment day 4 |
| Serum Total Testosterone Measured on Treatment Day 5 | TesTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | treatment day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall J Urban, M.D. | The University of Texas Medical Branch at Galveston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Medical Branch at Galveston | Galveston | Texas | 77555-0567 | United States |
46 subjects screened, 15 subjects did not qualify, 2 subjects did not choose to participate. 29 subjects began the study and 28 subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone Injection | Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection |
| FG001 | Testosterone Gel | Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days |
| FG002 | Testosterone Injection and Medrol 6 Day Dose Pack | Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. Testosterone injection: 100 mg single IM injection Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7 |
| FG003 | Medrol 6 Day Dose Pack | Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone Injection | Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection |
| BG001 | Testosterone Gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study) | Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | Posted | Mean | Standard Deviation | ng/dL | treatment day 1 |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Testosterone Injection | Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randall J Urban, Professor and Chair, Internal Medicine | University of Texas Medical Branch | 409-772-1176 | rurban@utmb.edu |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| C004648 | testosterone enanthate |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Testosterone gel | Drug | Testosterone gel 10 mg. administered topically daily for seven days |
|
|
| Medrol | Drug | Medrol 6 day dose pack with an additional 4mg dose on day 7 |
|
|
| Serum Total Testosterone Measured on Treatment Day 6 | Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | treatment day 6 |
| Serum Total Testosterone Measured on Treatment Day 7 | Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | treatment day 7 |
| Serum Total Testosterone Measured on Treatment Day 8 (Post Study) | Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | treatment day 8 |
| Serum Estradiol Measured on Treatment Day 1 (Baseline Study) | Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. | treatment day 1 |
| Serum Estradiol Measured on Treatment Day 8 (Post Study) | Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. | treatment day 8 |
| Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study) | Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. | treatment day 1 |
| Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study) | Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. | treatment day 8 |
| Hematocrit Measured on Treatment Day 1 (Baseline Study) | Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. | treatment day 1 |
| Hematocrit Measured on Treatment Day 8 (Post Study) | Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. | treatment day 8 |
| Total Cholesterol Measured on Treatment Day 1 (Baseline Study) | Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. | treatment day 1 |
| Total Cholesterol Measured on Treatment Day 8 (Post Study) | Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. | treatment day 8 |
| Triglycerides Measured on Treatment Day 1 (Baseline Study) | Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. | treatment day 1 |
| Triglycerides Measured on Treatment Day 8 (Post Study) | Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. | treatment day 8 |
| High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study) | High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. | treatment day 1 |
| High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study) | High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. | treatment day 8 |
| Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study) | Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. | treatment day 1 |
| Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study) | Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. | treatment day 8 |
| Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study) | Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. | treatment day 1 |
| Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study) | Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. | treatment day 8 |
| C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study) | C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. | treatment day 1 |
| C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study) | C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. | treatment day 8 |
| Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study) | Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. | treatment day 1 |
| Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study) | Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. | treatment day 8 |
| Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study) | Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. | treatment day 1 |
| Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study) | Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. | treatment day 8 |
| Insulin Measured on Treatment Day 1 (Baseline Study) | Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. | treatment day 1 |
| Insulin Measured on Treatment Day 8 (Post Study) | Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. | treatment day 8 |
| Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study) | Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. | treatment day 1 |
| Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study) | Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. | treatment day 8 |
| Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol | Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. | treatment day 1 - before exercise |
| Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol | Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. | treatment day 1 - after exercise |
| Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol | Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. | treatment day 8 - before exercise |
| Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol | Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. | treatment day 8 - after exercise |
| Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week | The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. This data is presented as the pre-treatment week average of study days -7 to -1. | Study days -7 to -1 (Pre - treatment) |
| Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week | The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. This data is presented as the treatment week average of study days 1-8. | Study days 1-7 (treatment week) |
Testosterone topical gel (Androgel 1%) 10 mg administered daily for seven days
Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days
| BG002 | Testosterone Injection and Medrol 6 Day Dose Pack | Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. Testosterone injection: 100 mg single IM injection Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7 |
| BG003 | Medrol 6 Day Dose Pack | Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7 |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Total Mass as Measured by DEXA | Mean | Standard Deviation | kilograms |
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| Lean Body Mass as measured by DEXA | Mean | Standard Deviation | kilograms |
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| Fat Mass as measured by DEXA | Mean | Standard Deviation | kilograms |
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| OG002 | Medrol 6 Day Dose Pack | Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7 |
| OG003 | Testosterone Injection and Medrol 6 Day Dose Pack | Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. Testosterone injection: 100 mg single IM injection Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7 |
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| Primary | Serum Total Testosterone Measured on Treatment Day 2 | Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | Posted | Mean | Standard Deviation | ng/dL | treatment day 2 |
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| Primary | Serum Total Testosterone Measured on Treatment Day 3 | TTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | Posted | Mean | Standard Deviation | ng/dL | treatment day 3 |
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| Primary | Serum Total Testosterone Measured on Treatment Day 4 | Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | One subject missed a testosterone monitoring visit for treatment day 4. | Posted | Mean | Standard Deviation | ng/dL | treatment day 4 |
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| Primary | Serum Total Testosterone Measured on Treatment Day 5 | TesTestosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | Posted | Mean | Standard Deviation | ng/dL | treatment day 5 |
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| Primary | Serum Total Testosterone Measured on Treatment Day 6 | Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | Posted | Mean | Standard Deviation | ng/dL | treatment day 6 |
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| Primary | Serum Total Testosterone Measured on Treatment Day 7 | Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | Posted | Mean | Standard Deviation | ng/dL | treatment day 7 |
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| Primary | Serum Total Testosterone Measured on Treatment Day 8 (Post Study) | Testosterone was measured daily during the treatment week (treatment days 1 through 8). Serum testosterone was analyzed by UTMB clinical laboratory. Normal ranges are 72-623 ng/dL. Baseline testosterone was drawn before testosterone administration. | Posted | Mean | Standard Deviation | ng/dL | treatment day 8 |
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| Primary | Serum Estradiol Measured on Treatment Day 1 (Baseline Study) | Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. | Posted | Mean | Standard Deviation | pg/mL | treatment day 1 |
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| Primary | Serum Estradiol Measured on Treatment Day 8 (Post Study) | Estradiol was measured during the treatment week (treatment days 1 and 8). Serum estradiol was analyzed by UTMB clinical laboratory. Normal ranges are 20-47 pg/mL. | Posted | Mean | Standard Deviation | pg/mL | treatment day 8 |
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| Primary | Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study) | Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. | Posted | Mean | Standard Deviation | ng/mL | treatment day 1 |
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| Primary | Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study) | Prostate Specific Antigen (PSA) was measured before and after treatment week (study treatment days 1 and 8). PSA was analyzed by UTMB clinical laboratory. Normal ranges are less than 4.0 ng/mL. | Posted | Mean | Standard Deviation | ng/mL | treatment day 8 |
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| Primary | Hematocrit Measured on Treatment Day 1 (Baseline Study) | Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. | Posted | Mean | Standard Deviation | percent | treatment day 1 |
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| Primary | Hematocrit Measured on Treatment Day 8 (Post Study) | Hematocrit was measured before and after treatment week (study treatment days 1 and 8). Hematocrit was analyzed by UTMB clinical laboratory. Normal ranges are 38.4% - 49.3%. | Posted | Mean | Standard Deviation | percent | treatment day 8 |
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| Primary | Total Cholesterol Measured on Treatment Day 1 (Baseline Study) | Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. | Posted | Mean | Standard Deviation | mg/dL | treatment day 1 |
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| Primary | Total Cholesterol Measured on Treatment Day 8 (Post Study) | Total Cholesterol was measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 120-200 mg/dL. | Posted | Mean | Standard Deviation | mg/dL | treatment day 8 |
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| Primary | Triglycerides Measured on Treatment Day 1 (Baseline Study) | Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. | Posted | Mean | Standard Deviation | mg/dL | treatment day 1 |
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| Primary | Triglycerides Measured on Treatment Day 8 (Post Study) | Triglycerides were measured before and after treatment week (study treatment days 1 and 8). Total cholesterol was analyzed by UTMB clinical laboratory. Normal ranges are 30-170 mg/dL. | Posted | Mean | Standard Deviation | mg/dL | treatment day 8 |
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| Primary | High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study) | High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. | Posted | Mean | Standard Deviation | mg/dL | treatment day 1 |
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| Primary | High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study) | High Density Lipoproteins (HDL) was measured before and after treatment week (study treatment days 1 and 8). HDL was analyzed by UTMB clinical laboratory. Normal ranges are higher than 35 mg/dL. | Posted | Mean | Standard Deviation | mg/dL | treatment day 8 |
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| Primary | Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study) | Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. | Posted | Mean | Standard Deviation | mg/dL | treatment day 1 |
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| Primary | Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study) | Low Density Lipoproteins (LDL) was measured before and after treatment week (study treatment days 1 and 8). LDL was analyzed by UTMB clinical laboratory. Normal ranges are less than 160 mg/dL. | Posted | Mean | Standard Deviation | mg/dL | treatment day 8 |
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| Primary | Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study) | Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. | Posted | Mean | Standard Deviation | mg/dL | treatment day 1 |
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| Primary | Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study) | Very Low Density Lipoproteins (VLDL) was measured before and after treatment week (study treatment days 1 and 8). VLDL was analyzed by UTMB clinical laboratory. Normal ranges are 5-60 mg/dL. | Posted | Mean | Standard Deviation | mg/dL | treatment day 8 |
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| Primary | C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study) | C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. | Posted | Mean | Standard Deviation | mg/dL | treatment day 1 |
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| Primary | C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study) | C-Reactive Protein (CRP) was measured during the treatment week (study treatment days 1 and 8). CRP was analyzed by UTMB clinical laboratory. Normal ranges are 0.0 - 0.8 mg/dL. | Posted | Mean | Standard Deviation | mg/dL | treatment day 8 |
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| Primary | Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study) | Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. | Posted | Mean | Standard Deviation | ug/dL | treatment day 1 |
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| Primary | Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study) | Dehydroepiandrosterone sulfate (DHEA-S) was measured before and after the treatment week on study treatment days 1 and 8. DHEA-S was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 28-290 ug/dL. | Posted | Mean | Standard Deviation | ug/dL | treatment day 8 |
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| Primary | Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study) | Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. | Posted | Mean | Standard Deviation | nmol/L | treatment day 1 |
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| Primary | Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study) | Sex Hormone Binding Globulin (SHBG) was measured before and after the treatment week on study treatment days 1 and 8. SHBG was analyzed by immunoassay on a Siemens Immulite 2000. Normal ranges are 10-57 nmol/L. | Posted | Mean | Standard Deviation | nmol/L | treatment day 8 |
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| Primary | Insulin Measured on Treatment Day 1 (Baseline Study) | Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. | Posted | Mean | Standard Deviation | uIu/mL | treatment day 1 |
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| Primary | Insulin Measured on Treatment Day 8 (Post Study) | Insulin was measured before and after the treatment week on study treatment days 1 and 8. Insulin was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is less than 25 uIu/mL. | Posted | Mean | Standard Deviation | uIu/mL | treatment day 8 |
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| Primary | Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study) | Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. | Posted | Mean | Standard Deviation | ng/mL | treatment day 1 |
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| Primary | Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study) | Insulin like growth factor 1 (IGF-1) was measured before and after the treatment week on study treatment days 1 and 8. IGF-1 was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 33-220 ng/mL. | Posted | Mean | Standard Deviation | ng/mL | treatment day 8 |
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| Primary | Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol | Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. | Posted | Mean | Standard Deviation | ug/dL | treatment day 1 - before exercise |
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| Primary | Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol | Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. | Posted | Mean | Standard Deviation | ug/dL | treatment day 1 - after exercise |
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| Primary | Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol | Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. | Posted | Mean | Standard Deviation | ug/dL | treatment day 8 - before exercise |
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| Primary | Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol | Cortisol was measured before and immediately after the exercise protocol, before and after the treatment week on study treatment days 1 and 8. Serum Cortisol was analyzed by immunoassay on a Siemens Immulite 2000. Normal range is 5-25 ug/dL. | Posted | Mean | Standard Deviation | ug/dL | treatment day 8 - after exercise |
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| Primary | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week | The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. This data is presented as the pre-treatment week average of study days -7 to -1. | Posted | Mean | Standard Deviation | units on a scale | Study days -7 to -1 (Pre - treatment) |
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| Primary | Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week | The Brief Fatigue Inventory is a 9 item questionnaire that assesses perceptual fatigue as well as fatigue interferences (e.g. interference with enjoyment of life), with "0" being no fatigue and "10" being as bad as you can imagine. The Global Fatigue score is calculated by averaging the answers of all the questions. This data is presented as the treatment week average of study days 1-8. | 1 subject did not complete the BFI during treatment week. | Posted | Mean | Standard Deviation | units on a scale | Study days 1-7 (treatment week) |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Testosterone Gel | Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days | 0 | 7 | 0 | 7 | 0 | 7 |
| EG002 | Testosterone Injection and Medrol 6 Day Dose Pack | Testosterone enanthate given as a single 100mg Intramuscular (IM) injection. Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. Testosterone injection: 100 mg single IM injection Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7 | 0 | 7 | 0 | 7 | 0 | 7 |
| EG003 | Medrol 6 Day Dose Pack | Medrol 6 day dose pack was administered as directed with daily doses decreasing by 4mg per day with an additional 4mg given on day 7. Day one dose: 24mg, day two dose: 20mg, day three dose: 16mg, day four dose: 12mg, day five dose: 8mg, day six dose: 4 mg, day seven dose: 4mg. Medrol: Medrol 6 day dose pack with an additional 4mg dose on day 7 | 0 | 8 | 0 | 8 | 0 | 8 |
Not provided
Not provided
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |