Completed
PHASE4
INTERVENTIONAL
NCT00957801
Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Detailed Description
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: 1. Testosterone by injection (100mg testosterone enanthate) administered on study day 1. 2. Testosterone by gel application (10g/day Androgel 1%) administered daily beginning on study day 1 through study day 7. 3. Methylpredisone (Medrol) dose pack beginning on study day 1 (24mg) and decreasing by 4mg each day, with an additional 4mg taken on study day 7. Study day 1 (24mg), study day 2 (20mg), study day 3 (16mg), study day 4 (12mg), study day 5 (8mg), study day 6 (4mg), study day 7 (4mg). 4. Testosterone by injection (100mg testosterone enanthate) administered on study day 1 and Methylpredisone (Medrol) dose pack beginning on study day 1 (24mg) and decreasing by 4mg each day, with an additional 4mg taken on study day 7. Study day 1 (24mg), study day 2 (20mg), study day 3 (16mg), study day 4 (12mg), study day 5 (8mg), study day 6 (4mg), study day 7 (4mg). 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.
Interventions
Name:
Testosterone injection
Type:
DRUG
Description:
100 mg single IM injection
Name:
Testosterone gel
Type:
DRUG
Description:
Testosterone gel 10 mg. administered topically daily for seven days
Name:
Medrol
Type:
DRUG
Description:
Medrol 6 day dose pack with an additional 4mg dose on day 7
Primary Outcomes
Measure:
Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
Serum Total Testosterone Measured on Treatment Day 2
TimeFrame:
treatment day 2
Description:
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.
Measure:
Serum Total Testosterone Measured on Treatment Day 3
TimeFrame:
treatment day 3
Description:
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.
Measure:
Serum Total Testosterone Measured on Treatment Day 4
TimeFrame:
treatment day 4
Description:
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.
Measure:
Serum Total Testosterone Measured on Treatment Day 5
TimeFrame:
treatment day 5
Description:
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.
Measure:
Serum Total Testosterone Measured on Treatment Day 6
TimeFrame:
treatment day 6
Description:
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.
Measure:
Serum Total Testosterone Measured on Treatment Day 7
TimeFrame:
treatment day 7
Description:
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.
Measure:
Serum Total Testosterone Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
Serum Estradiol Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
Serum Estradiol Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
Hematocrit Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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%.
Measure:
Hematocrit Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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%.
Measure:
Total Cholesterol Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
Total Cholesterol Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
Triglycerides Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
Triglycerides Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
Insulin Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
Insulin Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)
TimeFrame:
treatment day 1
Description:
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.
Measure:
Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)
TimeFrame:
treatment day 8
Description:
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.
Measure:
Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol
TimeFrame:
treatment day 1 - before exercise
Description:
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.
Measure:
Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol
TimeFrame:
treatment day 1 - after exercise
Description:
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.
Measure:
Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol
TimeFrame:
treatment day 8 - before exercise
Description:
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.
Measure:
Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol
TimeFrame:
treatment day 8 - after exercise
Description:
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.
Measure:
Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week
TimeFrame:
Study days -7 to -1 (Pre - treatment)
Description:
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.
Measure:
Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week
TimeFrame:
Study days 1-7 (treatment week)
Description:
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.
Trial Information
NCT ID
NCT00957801
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
The University of Texas Medical Branch, Galveston
Last Updated
December 15, 2025