Trial Outcomes & Findings for Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency (NCT NCT03716739)

Last Updated: 2026-07-16

Results Overview

The primary safety endpoint is the number of participants with biochemical recurrence of prostate cancer. Biochemical recurrence is defined as two or more consecutive serum PSA levels of 0.2 ng/mL or higher.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

136 participants

Primary outcome timeframe

the 12-week treatment and the 3-month follow-up

Results posted on

2026-07-16

Participant Flow

We initially planned to enroll 71 men per arm for a total of 142 men. As the study progressed, the loss-to-follow rates were substantially lower. Accordingly, with the concurrence of the trial's Data and Safety Monitoring Board (DSMB) and the NIA program staff, the target sample size was revised to 134 subjects as planned enrollment anticipating that it will still provide the same statistical power as originally assumed. In the end,136 subjects were enrolled and randomized.

Participant milestones

Participant milestones
Measure	Treatment Arm Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Overall Study STARTED	68	68
Overall Study COMPLETED	64	61
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Certain evaluations did not occur due to COVID-19 disruption or other reasons.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: the 12-week treatment and the 3-month follow-up

Population: The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the primary safety endpoint.

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=64 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Number of Participants With Biochemical Recurrence of Prostate Cancer Number of Participants with Biochemical recurrence of prostate cancer during the 12-week treatment	0 Participants	0 Participants
Number of Participants With Biochemical Recurrence of Prostate Cancer Number of Participants with Biochemical recurrence of prostate cancer during 3-month follow-up	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Week 6, Week 12

Population: Certain evaluations did not occur due to the COVID-related disruptions or other reasons.

The primary efficacy endpoint is the change from baseline in overall sexual activity, assessed using Psychosexual Diary Questionnaire (PDQ) Question 4. Subjects complete the PDQ questionnaire daily for 7 consecutive days before each visit. The PDQ covers 3 domains:1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity (PDQ-4) is assessed using a checklist of 12 sexual activities including sexual interactions, masturbation, intercourse, erection, orgasm, and ejaculation on each of the 7 days. The value is recorded as 0 (none) or 1 (any) for each of the sexual activities. Weekly value is the sum of "any" responses for the week. The sexual activity score is the average of the weekly values. The score ranges from 0 to 12, with 0 indicating no activity had taken place that week and with higher values indicating more sexual activity.

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=66 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change From Baseline in Overall Sexual Activity, Assessed Using Psychosexual Diary Questionnaire (PDQ) Question 4 Week 6	0.88 Score Interval 0.57 to 1.2	-0.01 Score Interval -0.33 to 0.31
Change From Baseline in Overall Sexual Activity, Assessed Using Psychosexual Diary Questionnaire (PDQ) Question 4 Week 12	0.99 Score Interval 0.67 to 1.31	0.06 Score Interval -0.26 to 0.38

SECONDARY outcome

Timeframe: Week 12

The secondary safety endpoint is change in PSA levels. Change from baseline in PSA could not be computed because the majority of the participants had undetectable PSA levels at baseline and post-baseline. Here, the number of participants with various PSA levels is reported.

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=64 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change in PSA Undetectable	64 Participants	63 Participants
Change in PSA >0.04 ng/mL and <0.1 ng/mL	1 Participants	1 Participants
Change in PSA >0.1 ng/mL and <0.2 ng/mL	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 6, Week 12

The secondary safety endpoint is the change from baseline in lower urinary tract symptoms, ascertained using the International Prostate Symptom Score (IPSS). The IPSS is a validated 8-question survey (7 symptom questions, 1 quality-of-life question) used to assess the severity of lower urinary tract symptoms (LUTS) associated with BPH, ranging from 0-35, with a higher score indicating a more severe negative symptoms.

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=64 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change From Baseline in Lower Urinary Tract Symptoms, Ascertained Using the International Prostate Symptom Score (IPSS) Week 6	0.17 Score Interval -0.75 to 1.1	-1.24 Score Interval -2.17 to -0.31
Change From Baseline in Lower Urinary Tract Symptoms, Ascertained Using the International Prostate Symptom Score (IPSS) Week 12	-0.70 Score Interval -1.64 to 0.23	-1.29 Score Interval -2.24 to -0.35

SECONDARY outcome

Timeframe: Week 6, Week 12

The secondary safety endpoint is the change from baseline in hemoglobin levels.

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=64 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change From Baseline in Hemoglobin Week 6	0.84 g/dL Interval 0.63 to 1.05	0.09 g/dL Interval -0.12 to 0.3
Change From Baseline in Hemoglobin Week 12	1.24 g/dL Interval 1.03 to 1.45	0.12 g/dL Interval -0.09 to 0.33

SECONDARY outcome

Timeframe: Week 6, Week 12

The secondary safety endpoint is the change from baseline in hematocrit levels.

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=64 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change From Baseline in Hematocrit Week 6	3.03 percentage of total blood volume Interval 2.38 to 3.68	0.12 percentage of total blood volume Interval -0.54 to 0.77
Change From Baseline in Hematocrit Week 12	4.27 percentage of total blood volume Interval 3.63 to 4.92	0.17 percentage of total blood volume Interval -0.48 to 0.82

SECONDARY outcome

Timeframe: Week 12

The secondary safety endpoint is the number of participants with erythrocytosis (confirmed hemoglobin \> 18.0 g/dL) in the two study arms.

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=64 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Number of Participants With Erythrocytosis in the Two Study Arms	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 12

The secondary safety endpoint is the number of participants with clinical prostate cancer recurrence in the two study arms.

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=64 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Number of Participants With Clinical Prostate Cancer Recurrence in the Two Study Arms	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 6, Week 12

Population: Certain evaluations did not occur due to COVID disruptions or other reasons.

The secondary efficacy endpoint is sexual desire, assessed by the DeRogatis Inventory of Sexual Function Sexual Desire (DISF-SD) Questionnaire. The DISF evaluates an individual's sexual health across five primary domains: sexual cognition/fantasy, arousal, behavior/experience, orgasm, and sexual drive/relationship. The Sexual Desire (SD) subset assesses an individual's subjective libido and frequency of sexual drive. The Sexual Desire score can range from 0 to 33, with a higher score indicating more sexual desire.

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=66 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change From Baseline in Sexual Desire, Assessed by the DeRogatis Inventory of Sexual Function Sexual Desire (DISF-SD) Questionnaire Week 6	3.53 Score Interval 2.24 to 4.83	0.87 Score Interval -0.43 to 2.17
Change From Baseline in Sexual Desire, Assessed by the DeRogatis Inventory of Sexual Function Sexual Desire (DISF-SD) Questionnaire Week 12	3.95 Score Interval 2.66 to 5.25	0.69 Score Interval -0.62 to 2.0

SECONDARY outcome

Timeframe: Week 6, Week 12

Population: Certain evaluations did not occur due to COVID disruptions or other reasons.

The secondary efficacy endpoint is erectile function will be assessed by the International Index of Erectile Function (IIEF) Questionnaire. The IIEF is a 15-item questionnaire that covers 4 domains of sexual function: erectile function, sexual desire, orgasmic function, and intercourse satisfaction. Each question has a potential score of 0 to 5 for a maximal score of 75 for the entire scale. Our focus in this study is on erectile function domain score, which can range from 0 to 30, lower scores indicating poor erectile function, and higher score indicating better erectile function.

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=66 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change in Erectile Function Assessed by the International Index of Erectile Function (IIEF) Questionnaire. Week 6	2.03 Score Interval 0.92 to 3.14	0.86 Score Interval -0.26 to 1.99
Change in Erectile Function Assessed by the International Index of Erectile Function (IIEF) Questionnaire. Week 12	2.05 Score Interval 0.94 to 3.15	1.36 Score Interval 0.24 to 2.48

SECONDARY outcome

Timeframe: Week 6, Week 12

Population: Certain evaluations did not occur due to COVID disruptions or other reasons.

The secondary efficacy endpoint is energy level, assessed using the Hypogonadism Energy Diary (HED). The total HED scale score is the sum of each of the six item weekly scores, with higher scores corresponding to greater energy level. The HED total score is linearly transformed to a scale of 0-100. Lower scores indicate lower energy (or more tiredness) and higher scores indicate more energy (less tiredness).

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=66 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change in Energy Level, Assessed Using the Hypogonadism Energy Diary (HED) Week 12	1.10 Score Interval -0.62 to 2.82	0.02 Score Interval -1.73 to 1.77
Change in Energy Level, Assessed Using the Hypogonadism Energy Diary (HED) Week 6	2.43 Score Interval 0.7 to 4.17	0.65 Score Interval -1.08 to 2.37

SECONDARY outcome

Timeframe: Week 6, Week 12

Population: Certain Evaluations did not occur due to COVID disruptions or other reasons.

Mood and well-being will be assessed by the Positive and Negative Affect Schedule (PANAS). The PANAS is a 20-item self-report measure to assess positive affect (PA) and negative affect (NA), with scores ranging from 10 to 50 for both the PA score and the NA score. For the PA score (10-50), higher scores represent higher levels of positive emotions, engagement, and enthusiasm. For the NA score (10-50), higher scores indicate higher levels of negative engagement, distress, and anxiety.

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=66 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change in Mood, Assessed by the Positive and Negative Affect Schedule (PANAS) Week 6: Positive Affect (PA) Score	1.59 Score Interval 0.4 to 2.78	1.46 Score Interval 0.27 to 2.65
Change in Mood, Assessed by the Positive and Negative Affect Schedule (PANAS) Week 6: Negative Affect (NA) Score	-1.11 Score Interval -2.03 to -0.18	-0.41 Score Interval -1.34 to 0.52
Change in Mood, Assessed by the Positive and Negative Affect Schedule (PANAS) Week 12: Positive Affect (PA) Score	1.55 Score Interval 0.36 to 2.75	0.49 Score Interval -0.72 to 1.7
Change in Mood, Assessed by the Positive and Negative Affect Schedule (PANAS) Week 12: Negative Affect (NA) Score	-1.51 Score Interval -2.45 to -0.58	0.56 Score Interval -0.38 to 1.5

SECONDARY outcome

Timeframe: Week 6, Week 12

Population: Certain evaluations did not occur due to COVID disruptions or other reasons.

The secondary efficacy endpoint is change from baseline in prostate cancer-related quality of life measured using the hormonal and sexual domains of the Expanded Prostate Cancer Index Composite (EPIC). Expanded Prostate Cancer Index Composite Instrument (EPIC-26) for Measuring Health-Related Quality of Life Among Prostate Cancer Survivors EPIC QOL is a 26-item questionnaire that assesses quality of life in 5 domains: urinary incontinence, urinary irritation/obstruction, bowel, sexual and vitality/hormonal domain scores. All domains for EPIC-26 are reported on a 0 to 100 score, with higher scores representing favorable Health-Related Quality of Life (HRQOL).

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=65 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change From Baseline in Prostate Cancer-related Quality of Life, Measured Using the Hormonal and Sexual Domains of the Expanded Prostate Cancer Index Composite (EPIC) Week 6: Hormonal Score	-0.21 Score Interval -2.34 to 1.91	1.59 Score Interval -0.59 to 3.77
Change From Baseline in Prostate Cancer-related Quality of Life, Measured Using the Hormonal and Sexual Domains of the Expanded Prostate Cancer Index Composite (EPIC) Week 6: Sexual Function Score	9.24 Score Interval 6.27 to 12.21	4.05 Score Interval 0.98 to 7.12
Change From Baseline in Prostate Cancer-related Quality of Life, Measured Using the Hormonal and Sexual Domains of the Expanded Prostate Cancer Index Composite (EPIC) Week 12: Hormonal Score	-0.18 Score Interval -2.31 to 1.94	0.03 Score Interval -2.18 to 2.25
Change From Baseline in Prostate Cancer-related Quality of Life, Measured Using the Hormonal and Sexual Domains of the Expanded Prostate Cancer Index Composite (EPIC) Week 12: Sexual Function Score	9.19 Score Interval 6.22 to 12.15	3.67 Score Interval 0.57 to 6.76

SECONDARY outcome

Timeframe: Week 6, Week 12

Population: Certain evaluations did not occur due to COVID disruptions or other reasons.

The secondary efficacy endpoint is change from baseline self-reported physical function, assessed using the physical function component of MOS SF-36 (PF10). The PF-10 (Physical Functioning Scale) is the 10-item subscale within the MOS SF-36 assessing the extent to which health limits physical activities, such as self-care, walking, and lifting. Scores range from 0 to 100, where higher numbers mean better physical function and fewer limitations.

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=66 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change From Baseline in Self-reported Physical Function, Assessed Using the Physical Function Component of MOS SF-36 (PF10) Week 6	2.38 Score Interval -0.21 to 4.97	3.69 Score Interval 1.07 to 6.3
Change From Baseline in Self-reported Physical Function, Assessed Using the Physical Function Component of MOS SF-36 (PF10) Week 12	1.44 Score Interval -1.15 to 4.03	2.13 Score Interval -0.52 to 4.78

SECONDARY outcome

Timeframe: Week 12

Population: Certain evaluations did not occur due to COVID disruptions or other reasons.

The secondary efficacy endpoint is change from baseline in performance-based physical function, assessed by measuring loaded stair climbing power.

Outcome measures

Outcome measures
Measure	Treatment Arm n=42 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=41 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change From Baseline in Performance-based Physical Function, Assessed by Measuring Loaded Stair Climbing Power	37.37 Watts Interval 17.55 to 57.2	3.89 Watts Interval -15.6 to 23.4

SECONDARY outcome

Timeframe: Week 12

Population: Certain evaluations did not occur due to COVID disruptions or other reasons.

The secondary efficacy endpoint is the change from baseline in Chest Press Max weight

Outcome measures

Outcome measures
Measure	Treatment Arm n=44 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=47 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change From Baseline in Chest Press Strength	51.81 Newtons Interval -3.58 to 107.2	-25.9 Newtons Interval -77.2 to 25.36

SECONDARY outcome

Timeframe: Week 12

Population: Certain evaluations did not occur due to COVID disruptions or other reasons.

The secondary efficacy endpoint is the change from baseline in Leg Press Max weight

Outcome measures

Outcome measures
Measure	Treatment Arm n=47 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=45 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change From Baseline in Leg Press Strength	145.9 Newtons Interval 71.45 to 222.4	100.6 Newtons Interval 30.2 to 171.0

SECONDARY outcome

Timeframe: Week 12

The secondary efficacy endpoint is aerobic capacity (VO2peak) achieved during cardiopulmonary exercise testing.

Outcome measures

Outcome measures
Measure	Treatment Arm n=41 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=44 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change in Aerobic Capacity (VO2peak) Achieved During Cardiopulmonary Exercise Testing	0.15 L/min Interval 0.06 to 0.23	-0.01 L/min Interval -0.09 to 0.07

SECONDARY outcome

Timeframe: Week 12

Population: Certain evaluations did not occur due to COVID disruptions or other reasons.

Change from baseline in whole body, appendicular, and trunk lean tissue mass measured using dual energy X-ray absorptiometry (DXA).

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=66 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change in Lean Body Mass Whole Body Lean Mass	2.36 kg Interval 1.88 to 2.84	-0.20 kg Interval -0.68 to 0.28
Change in Lean Body Mass Appendicular Lean Mass	1.32 kg Interval 1.04 to 1.6	-0.18 kg Interval -0.46 to 0.11
Change in Lean Body Mass Trunk Lean Mass	1.05 kg Interval 0.8 to 1.3	-0.01 kg Interval -0.26 to 0.24

SECONDARY outcome

Timeframe: Week 12

Population: Certain evaluations did not occur due to COVID disruptions or other reasons.

Change from baseline in whole body, appendicular, and trunk fat tissue mass measured using dual energy X-ray absorptiometry (DXA).

Outcome measures

Outcome measures
Measure	Treatment Arm n=66 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=66 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Change in Fat Body Mass Whole Body Lean Mass	-0.97 kg Interval -1.46 to -0.49	0.55 kg Interval 0.06 to 1.03
Change in Fat Body Mass Appendicular Lean Mass	-0.34 kg Interval -0.55 to -0.13	0.24 kg Interval 0.02 to 0.45
Change in Fat Body Mass Trunk Lean Mass	-0.66 kg Interval -0.96 to -0.36	0.32 kg Interval 0.02 to 0.62

Adverse Events

Treatment Arm

Serious events: 3 serious events

Other events: 49 other events

Deaths: 0 deaths

Control Arm

Serious events: 1 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Arm n=66 participants at risk Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=64 participants at risk Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Hepatobiliary disorders Gallbladder stone	0.00% 0/66 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	1.6% 1/64 • Number of events 1 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Respiratory, thoracic and mediastinal disorders Parapneumonic pleural effusion	1.5% 1/66 • Number of events 1 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	0.00% 0/64 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Respiratory, thoracic and mediastinal disorders Pneumonia	1.5% 1/66 • Number of events 1 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	0.00% 0/64 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Nervous system disorders Syncope	1.5% 1/66 • Number of events 1 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	0.00% 0/64 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.

Other adverse events

Other adverse events
Measure	Treatment Arm n=66 participants at risk Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=64 participants at risk Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory	10.6% 7/66 • Number of events 10 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	15.6% 10/64 • Number of events 15 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Cardiac disorders Cardiovascular	9.1% 6/66 • Number of events 7 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	10.9% 7/64 • Number of events 11 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Nervous system disorders Neurologic	6.1% 4/66 • Number of events 7 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	4.7% 3/64 • Number of events 3 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Gastrointestinal disorders Gastrointestinal	15.2% 10/66 • Number of events 13 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	7.8% 5/64 • Number of events 9 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Hepatobiliary disorders Hepatic/Biliary	6.1% 4/66 • Number of events 6 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	0.00% 0/64 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Reproductive system and breast disorders Genital/Urinary	4.5% 3/66 • Number of events 5 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	7.8% 5/64 • Number of events 7 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Endocrine disorders Endocrine/Metabolic	1.5% 1/66 • Number of events 2 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	3.1% 2/64 • Number of events 2 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Musculoskeletal and connective tissue disorders Musculoskeletal	37.9% 25/66 • Number of events 39 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	26.6% 17/64 • Number of events 32 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Blood and lymphatic system disorders Hematologic/Lymphatic	6.1% 4/66 • Number of events 11 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	6.2% 4/64 • Number of events 4 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Skin and subcutaneous tissue disorders Dermatologic	18.2% 12/66 • Number of events 17 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	15.6% 10/64 • Number of events 15 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Psychiatric disorders Psychiatric	1.5% 1/66 • Number of events 1 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	1.6% 1/64 • Number of events 1 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
Infections and infestations Infectious Disease	10.6% 7/66 • Number of events 7 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	3.1% 2/64 • Number of events 3 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.
General disorders Other	34.8% 23/66 • Number of events 25 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.	32.8% 21/64 • Number of events 36 • Baseline to Week 12 The study safety sample includes participants who received at least 1 study treatment administration. The participants who discontinued prior to study treatment administration due to COVID-19 disruption or other reasons are not included in the analysis for the safety endpoint. As a result, the study safety sample includes 130 subjects and not 136 subjects.

Additional Information

Dr Shalender Bhasin

Brigham and Women's Hospital

Phone: 617-525-9150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment Arm n=68 Participants Weekly IM administration of 100 mg testosterone cypionate for 12 weeks. Testosterone Cypionate 100 MG/ML: 100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.	Control Arm n=68 Participants Weekly IM administration of placebo for 12 weeks. Placebo: Placebo administered by intramuscular injection weekly for 12 weeks.	Total n=136 Participants Total of all reporting groups
Age, Continuous	69.0 Years STANDARD_DEVIATION 6.3 • n=68 Participants	68.1 Years STANDARD_DEVIATION 6.7 • n=68 Participants	68.6 Years STANDARD_DEVIATION 6.5 • n=136 Participants
Sex/Gender, Customized Male	68 Participants n=68 Participants	68 Participants n=68 Participants	136 Participants n=136 Participants
Race/Ethnicity, Customized Not Known	6 Participants n=68 Participants	4 Participants n=68 Participants	10 Participants n=136 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=68 Participants	1 Participants n=68 Participants	3 Participants n=136 Participants
Race/Ethnicity, Customized Non Hispanic or Latino	60 Participants n=68 Participants	63 Participants n=68 Participants	123 Participants n=136 Participants
Race/Ethnicity, Customized Asian	0 Participants n=68 Participants	1 Participants n=68 Participants	1 Participants n=136 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=68 Participants	9 Participants n=68 Participants	16 Participants n=136 Participants
Race/Ethnicity, Customized Other	0 Participants n=68 Participants	2 Participants n=68 Participants	2 Participants n=136 Participants
Race/Ethnicity, Customized White	61 Participants n=68 Participants	56 Participants n=68 Participants	117 Participants n=136 Participants
Sexual Activity (PDQ-Question 4 Mean Score 0-12)	1.6 Score STANDARD_DEVIATION 1.5 • n=66 Participants • Certain evaluations did not occur due to COVID-19 disruption or other reasons.	1.5 Score STANDARD_DEVIATION 1.2 • n=66 Participants • Certain evaluations did not occur due to COVID-19 disruption or other reasons.	1.6 Score STANDARD_DEVIATION 1.3 • n=132 Participants • Certain evaluations did not occur due to COVID-19 disruption or other reasons.
PSA <0.1 ng/mL	0 Participants n=68 Participants	0 Participants n=68 Participants	0 Participants n=136 Participants
Lower Urinary Tract Symptoms, Ascertained Using the International Prostate Symptom Score (IPSS)	6.8 Score STANDARD_DEVIATION 4.2 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	7.0 Score STANDARD_DEVIATION 4.8 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	6.9 Score STANDARD_DEVIATION 4.5 • n=132 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Hemoglobin	15.0 g/dL STANDARD_DEVIATION 1.1 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	14.6 g/dL STANDARD_DEVIATION 1.1 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	14.8 g/dL STANDARD_DEVIATION 1.1 • n=132 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Hematocrit	44.8 percentage of total blood STANDARD_DEVIATION 3.0 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	43.7 percentage of total blood STANDARD_DEVIATION 3.4 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	44.2 percentage of total blood STANDARD_DEVIATION 3.2 • n=132 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Sexual Desire, Assessed by the DeRogatis Inventory of Sexual Function Sexual Desire (DISF-SD)	15.6 Score STANDARD_DEVIATION 7.0 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	15.0 Score STANDARD_DEVIATION 7.2 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	15.3 Score STANDARD_DEVIATION 7.0 • n=132 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Erectile Function Assessed by the International Index of Erectile Function (IIEF) Questionnaire	6.1 Score STANDARD_DEVIATION 6.9 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	7.4 Score STANDARD_DEVIATION 7.4 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	6.7 Score STANDARD_DEVIATION 7.2 • n=132 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Chest Press Strength	689.1 Newtons STANDARD_DEVIATION 302.9 • n=44 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	680.0 Newtons STANDARD_DEVIATION 326.2 • n=47 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	684.4 Newtons STANDARD_DEVIATION 313.5 • n=91 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Leg Press Strength	2254.7 Newtons STANDARD_DEVIATION 760.9 • n=47 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	2366.9 Newtons STANDARD_DEVIATION 576.3 • n=45 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	2309.6 Newtons STANDARD_DEVIATION 675.6 • n=92 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Energy Level, Assessed Using the Hypogonadism Energy Diary (HED)	26.4 Score STANDARD_DEVIATION 8.5 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	29.0 Score STANDARD_DEVIATION 7.6 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	27.7 Score STANDARD_DEVIATION 8.1 • n=132 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Mood, Assessed by the Positive and Negative Affect Schedule (PANAS) Positive Affect (PA) Score	33.8 Score STANDARD_DEVIATION 7.6 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	34.9 Score STANDARD_DEVIATION 6.9 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	34.3 Score STANDARD_DEVIATION 7.2 • n=132 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Mood, Assessed by the Positive and Negative Affect Schedule (PANAS) Negative Affect (NA) Score	14.9 Score STANDARD_DEVIATION 5.5 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	14.5 Score STANDARD_DEVIATION 4.6 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	14.7 Score STANDARD_DEVIATION 5.0 • n=132 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Prostate Cancer-related Quality of Life, Measured Using the Hormonal and Sexual Domains of the Expan Sexual Function Score	24.5 Score STANDARD_DEVIATION 18.4 • n=64 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	26.6 Score STANDARD_DEVIATION 17.7 • n=63 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	25.5 Score STANDARD_DEVIATION 18.0 • n=127 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Prostate Cancer-related Quality of Life, Measured Using the Hormonal and Sexual Domains of the Expan Hormonal Score	85.6 Score STANDARD_DEVIATION 12.0 • n=65 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	88.6 Score STANDARD_DEVIATION 10.3 • n=64 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	87.1 Score STANDARD_DEVIATION 11.2 • n=129 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Self-reported Physical Function, Assessed Using the Physical Function Component of MOS SF-36 (PF10)	86.4 Score STANDARD_DEVIATION 18.2 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	86.7 Score STANDARD_DEVIATION 16.5 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	86.6 Score STANDARD_DEVIATION 17.3 • n=132 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Performance-based Physical Function, Assessed by Measuring Loaded Stair Climbing Power	404.0 Watts STANDARD_DEVIATION 158.4 • n=42 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	444.6 Watts STANDARD_DEVIATION 107.7 • n=41 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	424.0 Watts STANDARD_DEVIATION 136.5 • n=83 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Aerobic Capacity (VO2peak) Achieved During Cardiopulmonary Exercise Testing	1.9 L/min STANDARD_DEVIATION 0.4 • n=41 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	2.0 L/min STANDARD_DEVIATION 0.5 • n=44 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	1.9 L/min STANDARD_DEVIATION 0.5 • n=85 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Lean Body Mass Whole Body Lean Mass	55.0 kg STANDARD_DEVIATION 6.6 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	55.4 kg STANDARD_DEVIATION 7.0 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	55.2 kg STANDARD_DEVIATION 6.8 • n=132 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Lean Body Mass Appendicular Lean Mass	24.3 kg STANDARD_DEVIATION 3.2 • n=68 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	24.7 kg STANDARD_DEVIATION 3.5 • n=68 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	24.5 kg STANDARD_DEVIATION 3.3 • n=136 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Lean Body Mass Trunk Lean Mass	27.2 kg STANDARD_DEVIATION 3.4 • n=68 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	27.2 kg STANDARD_DEVIATION 3.7 • n=68 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	27.2 kg STANDARD_DEVIATION 3.5 • n=136 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Fat Body Mass Whole Body Fat Mass	30.7 kg STANDARD_DEVIATION 8.7 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	31.0 kg STANDARD_DEVIATION 7.7 • n=66 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	30.9 kg STANDARD_DEVIATION 8.2 • n=132 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Fat Body Mass Appendicular Fat Mass	12.7 kg STANDARD_DEVIATION 3.7 • n=68 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	12.7 kg STANDARD_DEVIATION 3.0 • n=68 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	12.7 kg STANDARD_DEVIATION 3.3 • n=136 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.
Fat Body Mass Trunk Fat Mass	16.6 kg STANDARD_DEVIATION 5.3 • n=68 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	17.0 kg STANDARD_DEVIATION 5.0 • n=68 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.	16.8 kg STANDARD_DEVIATION 5.1 • n=136 Participants • Certain evaluations did not occur due to COVID disruptions or other reasons.