Trial Outcomes & Findings for Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men (NCT NCT00957801)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

29 participants

Primary outcome timeframe

treatment day 1

Results posted on

2018-05-08

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Testosterone Injection Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	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	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
Overall Study STARTED	7	7	7	8
Overall Study COMPLETED	7	7	7	7
Overall Study NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Testosterone Injection Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	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	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
Overall Study Withdrawal by Subject	0	0	0	1

Baseline Characteristics

Anabolic and Inflammatory Responses to Short-Term Testosterone Administration in Older Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel (Androgel 1%) 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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	Medrol 6 Day Dose Pack n=8 Participants 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	Total n=29 Participants Total of all reporting groups
Age, Continuous	72 years STANDARD_DEVIATION 4 • n=5 Participants	73 years STANDARD_DEVIATION 5 • n=7 Participants	73 years STANDARD_DEVIATION 7.5 • n=5 Participants	71 years STANDARD_DEVIATION 7 • n=4 Participants	72 years STANDARD_DEVIATION 6 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	29 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	28 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	27 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	7 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	8 Participants n=4 Participants	29 Participants n=21 Participants
Total Mass as Measured by DEXA	84.2 kilograms STANDARD_DEVIATION 82.83 • n=5 Participants	89.6 kilograms STANDARD_DEVIATION 89.7 • n=7 Participants	77.51 kilograms STANDARD_DEVIATION 76.93 • n=5 Participants	89.04 kilograms STANDARD_DEVIATION 89.15 • n=4 Participants	84.42 kilograms STANDARD_DEVIATION 15.8 • n=21 Participants
Lean Body Mass as measured by DEXA	52.60 kilograms STANDARD_DEVIATION 51.42 • n=5 Participants	53.06 kilograms STANDARD_DEVIATION 52.66 • n=7 Participants	49.22 kilograms STANDARD_DEVIATION 47.85 • n=5 Participants	57.34 kilograms STANDARD_DEVIATION 57.84 • n=4 Participants	52.77 kilograms STANDARD_DEVIATION 7.73 • n=21 Participants
Fat Mass as measured by DEXA	28.74 kilograms STANDARD_DEVIATION 28.64 • n=5 Participants	33.32 kilograms STANDARD_DEVIATION 33.82 • n=7 Participants	25.33 kilograms STANDARD_DEVIATION 26.12 • n=5 Participants	28.40 kilograms STANDARD_DEVIATION 28.01 • n=4 Participants	28.59 kilograms STANDARD_DEVIATION 9.99 • n=21 Participants

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Serum Total Testosterone Measured Before Treatment on Treatment Day 1 (Baseline Study)	307.57 ng/dL Standard Deviation 106.09	363.43 ng/dL Standard Deviation 95.76	408.17 ng/dL Standard Deviation 200.61	318.68 ng/dL Standard Deviation 129.68

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Serum Total Testosterone Measured on Treatment Day 2	980.86 ng/dL Standard Deviation 389.58	526.71 ng/dL Standard Deviation 127.59	191.87 ng/dL Standard Deviation 90.35	675.86 ng/dL Standard Deviation 316.83

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Serum Total Testosterone Measured on Treatment Day 3	828.71 ng/dL Standard Deviation 375.94	527.43 ng/dL Standard Deviation 183.70	206.0 ng/dL Standard Deviation 89.35	673.29 ng/dL Standard Deviation 299.30

PRIMARY outcome

Timeframe: treatment day 4

Population: One subject missed a testosterone monitoring visit for 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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=6 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Serum Total Testosterone Measured on Treatment Day 4	779.57 ng/dL Standard Deviation 399.73	441.71 ng/dL Standard Deviation 146.99	271.6 ng/dL Standard Deviation 134.93	734.57 ng/dL Standard Deviation 277.34

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Serum Total Testosterone Measured on Treatment Day 5	722.0 ng/dL Standard Deviation 302.10	460.14 ng/dL Standard Deviation 211.31	246.33 ng/dL Standard Deviation 131.30	669.71 ng/dL Standard Deviation 291.02

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Serum Total Testosterone Measured on Treatment Day 6	629.0 ng/dL Standard Deviation 272.56	536.43 ng/dL Standard Deviation 269.53	284.5 ng/dL Standard Deviation 166.0	645.14 ng/dL Standard Deviation 282.11

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Serum Total Testosterone Measured on Treatment Day 7	578.29 ng/dL Standard Deviation 173.58	485.86 ng/dL Standard Deviation 211.57	320.0 ng/dL Standard Deviation 113.06	579.57 ng/dL Standard Deviation 170.04

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Serum Total Testosterone Measured on Treatment Day 8 (Post Study)	454.29 ng/dL Standard Deviation 57.12	435.14 ng/dL Standard Deviation 180.11	340.17 ng/dL Standard Deviation 127.27	481.14 ng/dL Standard Deviation 141.08

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Serum Estradiol Measured on Treatment Day 1 (Baseline Study)	22.86 pg/mL Standard Deviation 10.32	33.69 pg/mL Standard Deviation 17.04	36.33 pg/mL Standard Deviation 12.12	34.71 pg/mL Standard Deviation 10.95

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Serum Estradiol Measured on Treatment Day 8 (Post Study)	48.29 pg/mL Standard Deviation 12.20	33.43 pg/mL Standard Deviation 19.48	30.83 pg/mL Standard Deviation 7.05	47.14 pg/mL Standard Deviation 34.87

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Prostate Specific Antigen (PSA) Measured on Treatment Day 1 (Baseline Study)	1.92 ng/mL Standard Deviation 1.13	2.33 ng/mL Standard Deviation 1.60	1.85 ng/mL Standard Deviation 1.02	1.83 ng/mL Standard Deviation 1.25

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Prostate Specific Antigen (PSA) Measured on Treatment Day 8 (Post Study)	1.98 ng/mL Standard Deviation 1.00	2.32 ng/mL Standard Deviation 1.64	1.78 ng/mL Standard Deviation 1.05	2.07 ng/mL Standard Deviation 1.60

PRIMARY outcome

Timeframe: treatment day 1

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%.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Hematocrit Measured on Treatment Day 1 (Baseline Study)	39.17 percent Standard Deviation 2.39	38.4 percent Standard Deviation 3.71	40.45 percent Standard Deviation 2.92	39.86 percent Standard Deviation 2.33

PRIMARY outcome

Timeframe: treatment day 8

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%.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Hematocrit Measured on Treatment Day 8 (Post Study)	38.74 percent Standard Deviation 2.15	37.23 percent Standard Deviation 3.57	40.53 percent Standard Deviation 2.47	39.24 percent Standard Deviation 2.72

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Total Cholesterol Measured on Treatment Day 1 (Baseline Study)	171.29 mg/dL Standard Deviation 35.72	165.57 mg/dL Standard Deviation 34.89	168.00 mg/dL Standard Deviation 24.51	156.71 mg/dL Standard Deviation 27.32

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Total Cholesterol Measured on Treatment Day 8 (Post Study)	172 mg/dL Standard Deviation 46.45	162.86 mg/dL Standard Deviation 37.64	166.17 mg/dL Standard Deviation 23.57	141.86 mg/dL Standard Deviation 21.64

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Triglycerides Measured on Treatment Day 1 (Baseline Study)	140.42 mg/dL Standard Deviation 50.35	164.0 mg/dL Standard Deviation 44.45	122.5 mg/dL Standard Deviation 74.89	119.71 mg/dL Standard Deviation 35.04

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Triglycerides Measured on Treatment Day 8 (Post Study)	112.57 mg/dL Standard Deviation 49.90	160.0 mg/dL Standard Deviation 58.91	155.17 mg/dL Standard Deviation 119.23	116.28 mg/dL Standard Deviation 22.94

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
High-Density Lipoproteins (HDL) Measured on Treatment Day 1 (Baseline Study)	40.29 mg/dL Standard Deviation 6.29	38.86 mg/dL Standard Deviation 13.47	46.50 mg/dL Standard Deviation 8.94	42.14 mg/dL Standard Deviation 6.57

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
High-Density Lipoproteins (HDL) Measured on Treatment Day 8 (Post Study)	41.29 mg/dL Standard Deviation 9.60	36.71 mg/dL Standard Deviation 8.83	47.67 mg/dL Standard Deviation 5.35	43.43 mg/dL Standard Deviation 6.24

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Low-Density Lipoproteins (LDL) Measured on Treatment Day 1 (Baseline Study)	103.0 mg/dL Standard Deviation 27.76	93.57 mg/dL Standard Deviation 36.47	96.83 mg/dL Standard Deviation 18.24	90.71 mg/dL Standard Deviation 26.57

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Low-Density Lipoproteins (LDL) Measured on Treatment Day 8 (Post Study)	104.0 mg/dL Standard Deviation 43.64	94.57 mg/dL Standard Deviation 40.61	87.5 mg/dL Standard Deviation 13.91	75.14 mg/dL Standard Deviation 19.79

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 1 (Baseline Study)	28 mg/dL Standard Deviation 10.13	33.14 mg/dL Standard Deviation 8.51	24.67 mg/dL Standard Deviation 14.99	23.86 mg/dL Standard Deviation 7.03

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Very Low-Density Lipoproteins (VLDL) Measured on Treatment Day 8 (Post Study)	26.71 mg/dL Standard Deviation 8.50	29.29 mg/dL Standard Deviation 11.07	31.0 mg/dL Standard Deviation 24.02	24.71 mg/dL Standard Deviation 6.07

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
C-Reactive Protein (CRP) Measured on Treatment Day 1 (Baseline Study)	0.47 mg/dL Standard Deviation 0.23	0.33 mg/dL Standard Deviation 0.08	0.32 mg/dL Standard Deviation 0.4	0.4 mg/dL Standard Deviation 0.22

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
C-Reactive Protein (CRP) Measured on Treatment Day 8 (Post Study)	0.47 mg/dL Standard Deviation 0.22	0.31 mg/dL Standard Deviation 0.04	0.32 mg/dL Standard Deviation 0.4	0.3 mg/dL Standard Deviation 0

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 1 (Baseline Study)	46.34 ug/dL Standard Deviation 48.14	34.16 ug/dL Standard Deviation 16.54	62.55 ug/dL Standard Deviation 53.20	46.07 ug/dL Standard Deviation 51.56

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Dehydroepiandrosterone Sulfate (DHEA-S) Measured on Treatment Day 8 (Post Study)	37.96 ug/dL Standard Deviation 25.25	35.54 ug/dL Standard Deviation 14.52	34.74 ug/dL Standard Deviation 30.08	36.07 ug/dL Standard Deviation 35.77

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 1 (Baseline Study)	21.78 nmol/L Standard Deviation 11.56	19.86 nmol/L Standard Deviation 8.51	25.66 nmol/L Standard Deviation 12.85	24.70 nmol/L Standard Deviation 9.63

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Sex Hormone Binding Globulin (SHBG) Measured on Treatment Day 8 (Post Study)	17.62 nmol/L Standard Deviation 4.8	20.13 nmol/L Standard Deviation 9.72	19.22 nmol/L Standard Deviation 11.71	14.57 nmol/L Standard Deviation 6.88

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Insulin Measured on Treatment Day 1 (Baseline Study)	8.53 uIu/mL Standard Deviation 4.11	10.28 uIu/mL Standard Deviation 8.09	4.09 uIu/mL Standard Deviation 2.08	9.89 uIu/mL Standard Deviation 10.0

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Insulin Measured on Treatment Day 8 (Post Study)	7.47 uIu/mL Standard Deviation 3.90	10.58 uIu/mL Standard Deviation 7.13	3.92 uIu/mL Standard Deviation 1.73	3.89 uIu/mL Standard Deviation 1.80

PRIMARY outcome

Timeframe: treatment day 1

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 1 (Baseline Study)	71.77 ng/mL Standard Deviation 33.99	69.2 ng/mL Standard Deviation 33.00	61.42 ng/mL Standard Deviation 40.36	90.74 ng/mL Standard Deviation 65.38

PRIMARY outcome

Timeframe: treatment day 8

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Insulin Like Growth Factor 1 (IGF-1) Measured on Treatment Day 8 (Post Study)	80.16 ng/mL Standard Deviation 39.07	72.11 ng/mL Standard Deviation 26.20	69.17 ng/mL Standard Deviation 47.64	54.86 ng/mL Standard Deviation 47.34

PRIMARY outcome

Timeframe: treatment day 1 - before exercise

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Cortisol Measured on Treatment Day 1 (Baseline Study) BEFORE Exercise Protocol	7.25 ug/dL Standard Deviation 2.16	6.00 ug/dL Standard Deviation 1.67	6.64 ug/dL Standard Deviation 1.71	6.28 ug/dL Standard Deviation 1.61

PRIMARY outcome

Timeframe: treatment day 1 - after exercise

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Cortisol Measured on Treatment Day 1 (Baseline Study) AFTER Exercise Protocol	7.71 ug/dL Standard Deviation 3.16	7.20 ug/dL Standard Deviation 2.71	4.76 ug/dL Standard Deviation 1.17	4.15 ug/dL Standard Deviation 1.64

PRIMARY outcome

Timeframe: treatment day 8 - before exercise

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Cortisol Measured on Treatment Day 8 (Post Study) BEFORE Exercise Protocol	7.84 ug/dL Standard Deviation 3.13	5.97 ug/dL Standard Deviation 2.18	6.28 ug/dL Standard Deviation 2.90	5.19 ug/dL Standard Deviation 2.76

PRIMARY outcome

Timeframe: treatment day 8 - after exercise

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Cortisol Measured on Treatment Day 8 (Post Study) AFTER Exercise Protocol	7.05 ug/dL Standard Deviation 2.48	6.28 ug/dL Standard Deviation 3.41	4.40 ug/dL Standard Deviation 1.90	5.78 ug/dL Standard Deviation 2.38

PRIMARY outcome

Timeframe: Study days -7 to -1 (Pre - treatment)

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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=7 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) in the Pre-treatment Week	2.25 units on a scale Standard Deviation 0.41	1.47 units on a scale Standard Deviation 0.26	2.26 units on a scale Standard Deviation 0.37	1.86 units on a scale Standard Deviation 0.22

PRIMARY outcome

Timeframe: Study days 1-7 (treatment week)

Population: 1 subject did not complete the BFI during 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.

Outcome measures

Outcome measures
Measure	Testosterone Injection n=7 Participants Testosterone enanthate given as a single 100 mg Intramuscular (IM) injection Testosterone injection: 100 mg single IM injection	Testosterone Gel n=7 Participants Testosterone topical gel 10 mg administered daily for seven days Testosterone gel: Testosterone gel 10 mg. administered topically daily for seven days	Medrol 6 Day Dose Pack n=6 Participants 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	Testosterone Injection and Medrol 6 Day Dose Pack n=7 Participants 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
Global Fatigue Score as Measured by Brief Fatigue Inventory (BFI) During the Treatment Week	1.84 units on a scale Standard Deviation 0.30	1.79 units on a scale Standard Deviation 0.16	2.19 units on a scale Standard Deviation 0.48	1.57 units on a scale Standard Deviation 0.13

Adverse Events

Testosterone Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Testosterone Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Testosterone Injection and Medrol 6 Day Dose Pack

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Medrol 6 Day Dose Pack

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Randall J Urban, Professor and Chair, Internal Medicine

University of Texas Medical Branch

Phone: 409-772-1176

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place