Trial Outcomes & Findings for Testosterone Administration and ACL Reconstruction in Men (NCT NCT01595581)

Results Overview

Relative changes in lean mass from 2 weeks prior to surgery to 6 weeks, 12 weeks, and 24 weeks following surgery between the two groups.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

14 participants

Primary outcome timeframe

6, 12, and 24 weeks post operative

Results posted on

2022-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Testosterone Testosterone: 8 weeks supraphysiologic dose testosterone enanthate	Placebo Saline: Placebo for 8 weeks
Overall Study STARTED	7	7
Overall Study COMPLETED	6	7
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Testosterone Testosterone: 8 weeks supraphysiologic dose testosterone enanthate	Placebo Saline: Placebo for 8 weeks
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Testosterone n=7 Participants Testosterone: 8 weeks 200mg dose testosterone enanthate	Placebo n=7 Participants Saline: Placebo for 8 weeks	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=7 Participants	7 Participants n=7 Participants	14 Participants n=14 Participants
Age, Categorical >=65 years	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants
Age, Continuous	30.4 years STANDARD_DEVIATION 9.3 • n=7 Participants	26.2 years STANDARD_DEVIATION 4.1 • n=7 Participants	28.2 years STANDARD_DEVIATION 6.7 • n=14 Participants
Sex: Female, Male Female	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants
Sex: Female, Male Male	7 Participants n=7 Participants	7 Participants n=7 Participants	14 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 participants n=7 Participants	7 participants n=7 Participants	14 participants n=14 Participants

PRIMARY outcome

Timeframe: 6, 12, and 24 weeks post operative

Population: Region of enrollment from the Los Angeles area.

Relative changes in lean mass from 2 weeks prior to surgery to 6 weeks, 12 weeks, and 24 weeks following surgery between the two groups.

Outcome measures

Outcome measures
Measure	Testosterone n=6 Participants Testosterone: 8 weeks supraphysiologic dose testosterone enanthate. Ethnicity: 4 White, 2 Asian, 1 Black	Placebo n=7 Participants Saline: Placebo for 8 weeks Ethnicity: 4 White, 1 Asian, 2 Hispanic
Changes in Lean Mass 6 weeks post op	2.8 kg Standard Deviation 1.7	-0.1 kg Standard Deviation 1.5
Changes in Lean Mass 12 weeks post op	2.16 kg Standard Deviation 3.48	0.01 kg Standard Deviation 1.08
Changes in Lean Mass 24 weeks post op	2.13 kg Standard Deviation 5.3	1.05 kg Standard Deviation 1.18

SECONDARY outcome

Timeframe: 6 weeks, 12 weeks, 24 weeks post surgery

Population: Region of enrollment from the Los Angeles area.

Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) from 2 weeks prior to surgery to 6, 12, and 24 weeks post surgery. KOOS is scored from 0 to 100 with 0 representing extreme knee problems and 100 representing normal knee function.

Outcome measures

Outcome measures
Measure	Testosterone n=6 Participants Testosterone: 8 weeks supraphysiologic dose testosterone enanthate. Ethnicity: 4 White, 2 Asian, 1 Black	Placebo n=7 Participants Saline: Placebo for 8 weeks Ethnicity: 4 White, 1 Asian, 2 Hispanic
KOOS Scores 6 weeks post op	63.2 score on a scale Standard Deviation 10.6	65.5 score on a scale Standard Deviation 13
KOOS Scores 12 weeks post op	76.7 score on a scale Standard Deviation 9.9	73.2 score on a scale Standard Deviation 15
KOOS Scores 24 weeks post op	84 score on a scale Standard Deviation 9.4	86.6 score on a scale Standard Deviation 8.3

SECONDARY outcome

Timeframe: 6, 12, and 24 weeks post surgery

Population: Region of enrollment from the Los Angeles area.

Changes in muscle strength from the start of rehabilitation to 6, 12, and 24 weeks following surgery between the two groups in the injured limb.

Outcome measures

Outcome measures
Measure	Testosterone n=6 Participants Testosterone: 8 weeks supraphysiologic dose testosterone enanthate. Ethnicity: 4 White, 2 Asian, 1 Black	Placebo n=7 Participants Saline: Placebo for 8 weeks Ethnicity: 4 White, 1 Asian, 2 Hispanic
Strength 6 weeks post op	-53.5 Nm Standard Deviation 35.8	-33.4 Nm Standard Deviation 37.4
Strength 12 weeks post op	-18.3 Nm Standard Deviation 52.7	-6.6 Nm Standard Deviation 40.3
Strength 24 weeks post op	19.2 Nm Standard Deviation 60.9	19.0 Nm Standard Deviation 33.9

Adverse Events

Testosterone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Edward Schroeder

University of Southern California

Phone: 323-442-2498

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place