Study: NCT02248701

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Hospitalization due to severe acute respiratory syndrome (SARS)-CoV-2 (COVID-19) infection
Frequency: 1 affected / 7 at risk

Adverse event: aldolase, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (\<=8.1 U/L); test performed on only 1 participant at request of study physician
Frequency: 1 affected / 7 at risk

Adverse event: anion gap, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (5-15 mmol/L)
Frequency: 1 affected / 7 at risk

Adverse event: alanine aminotransferase (ALT), high
Serious: no
Organ System: Investigations
Notes: above standard reference range (0-40 U/L)
Frequency: 2 affected / 7 at risk

Adverse event: aspartate aminotransferase (AST), high
Serious: no
Organ System: Investigations
Notes: above standard reference range (0-45 U/L)
Frequency: 1 affected / 7 at risk

Adverse event: calcium, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (8.4-10.5 mg/dL)
Frequency: 1 affected / 7 at risk

Adverse event: total cholesterol, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (0-199 mg/dL); all participants in testosterone enanthate, finasteride group exhibited cholesterol values above standard reference range at baseline (before treatment initiation)
Frequency: 4 affected / 7 at risk

Adverse event: CO2, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (23-32 mmol/L)
Frequency: 2 affected / 7 at risk

Adverse event: creatine phosphokinase (CPK), high
Serious: no
Organ System: General disorders
Notes: above standard reference range (5-180 U/L); test performed on only 1 participant at request of study physician
Frequency: 1 affected / 7 at risk

Adverse event: creatinine, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (0.5-1.2 mg/dL)
Frequency: 2 affected / 7 at risk

Adverse event: C-reactive protein (CRP), high
Serious: no
Organ System: General disorders
Notes: above standard reference range (\<0.1-0.4 mg/dL); 3 of 6 testosterone enanthate, finasteride participants and 1 of 3 placebo participants with elevated CRP exhibited values above standard reference range at baseline (before treatment initiation)
Frequency: 6 affected / 7 at risk

Adverse event: dihydrotestosterone, low
Serious: no
Organ System: Investigations
Notes: below standard reference range (16-79 ng/dL)
Frequency: 5 affected / 7 at risk

Adverse event: Oedema
Serious: no
Organ System: Investigations
Notes: present in upper and lower extremities
Frequency: 1 affected / 7 at risk

Adverse event: estradiol, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (\<=29 pg/mL)
Frequency: 7 affected / 7 at risk

Adverse event: eosinophils, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (0-3%)
Frequency: 5 affected / 7 at risk

Adverse event: erythropoietin, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (2.6-18.5 mIU/mL)
Frequency: 2 affected / 7 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: transient depression, self reported
Frequency: 1 affected / 7 at risk

Adverse event: glucose, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (65-99 mg/dL); 7 of 7 participants in testosterone enanthate, finasteride group and 3 of 5 participants in placebo group exhibited glucose values above standard reference range at baseline (before treatment initiation)
Frequency: 7 affected / 7 at risk

Adverse event: granulocytes, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (54-65%)
Frequency: 1 affected / 7 at risk

Adverse event: granulocytes, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (54-65%)
Frequency: 4 affected / 7 at risk

Adverse event: HDL cholesterol, low
Serious: no
Organ System: Investigations
Notes: below standard reference range (\>=40 mg/dL); 3 of 5 participants in testosterone enanthate, finasteride group and 2 of 2 participants in placebo group with low HDL exhibited values below reference range at baseline (before treatment initiation)
Frequency: 5 affected / 7 at risk

Adverse event: hematocrit, low
Serious: no
Organ System: Investigations
Notes: below standard reference range (41-52%)
Frequency: 1 affected / 7 at risk

Adverse event: hemoglobin, low
Serious: no
Organ System: Investigations
Notes: below standard reference range (13.9-18 g/dL)
Frequency: 2 affected / 7 at risk

Adverse event: insulin, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (\<=19.6 uIU/mL)
Frequency: 2 affected / 7 at risk

Adverse event: potassium, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (3.5-5.0 mmol/L)
Frequency: 1 affected / 7 at risk

Adverse event: LDL cholesterol, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (\<=129 mg/dL); 3 of 3 participants in testosterone enanthate, finasteride group with high LDL cholesterol exhibited values above standard reference range at baseline (before treatment initiation)
Frequency: 3 affected / 7 at risk

Adverse event: lymphocytes, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (25-33%)
Frequency: 3 affected / 7 at risk

Adverse event: lymphocytes, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (25-33%)
Frequency: 3 affected / 7 at risk

Adverse event: mean corpuscular hemoglobin, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (27-33.3 pg)
Frequency: 2 affected / 7 at risk

Adverse event: mean corpuscular hemoglobin concentration, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (31.8-37.1 g/dL)
Frequency: 3 affected / 7 at risk

Adverse event: mean corpuscle volume, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (80-98 um\^3)
Frequency: 1 affected / 7 at risk

Adverse event: monocytes, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (3-7%); 6 of 7 participants in testosterone enanthate, finasteride group and 3 of 5 participants in placebo group exhibited monocyte values above standard reference range at baseline (before treatment initiation)
Frequency: 7 affected / 7 at risk

Adverse event: mean platelet volume, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (7.4-10.5 um\^3)
Frequency: 4 affected / 7 at risk

Adverse event: myelocytes, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (0)
Frequency: 1 affected / 7 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self reported
Frequency: 3 affected / 7 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Notes: ear infection
Frequency: 1 affected / 7 at risk

Adverse event: penile shrinkage
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self reported
Frequency: 1 affected / 7 at risk

Adverse event: total protein, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (6.0-8.2 g/dL)
Frequency: 1 affected / 7 at risk

Adverse event: prostate-specific antigen (PSA), high
Serious: no
Organ System: Investigations
Notes: above standard reference range (0-4 ng/mL or increase \>1.4 ng/mL vs baseline); 1 of 2 participants in testosterone enanthate, finasteride group with high PSA tested positive for urinary tract infection 2 different times with PSA renormalizing
Frequency: 2 affected / 7 at risk

Adverse event: red blood cell count, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (4.44-6.1 M/cmm)
Frequency: 2 affected / 7 at risk

Adverse event: red blood cell distribution width, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (39.0-52.2 fL)
Frequency: 3 affected / 7 at risk

Adverse event: segmented neurtrophils, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (54-65%)
Frequency: 1 affected / 7 at risk

Adverse event: testicular size reduced
Serious: no
Organ System: Reproductive system and breast disorders
Notes: self reported outcome
Frequency: 1 affected / 7 at risk

Adverse event: testosterone, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (193-836 ng/dL)
Frequency: 5 affected / 7 at risk

Adverse event: testosterone, low
Serious: no
Organ System: Investigations
Notes: below standard reference range (193-836 ng/dL)
Frequency: 2 affected / 7 at risk

Adverse event: triglycerides, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (0-149 mg/dL)
Frequency: 4 affected / 7 at risk

Adverse event: urea nitrogen, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (9-20 mg/dL)
Frequency: 2 affected / 7 at risk

Adverse event: urobilinogen, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (0.00-1.99 mg/dL)
Frequency: 1 affected / 7 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: As a result of self-catheterization
Frequency: 1 affected / 7 at risk

Adverse event: white blood cell count, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (4.6-10.8 k/cmm)
Frequency: 1 affected / 7 at risk

Adverse event: white blood cell count, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (4.6-10.8 k/cmm)
Frequency: 1 affected / 7 at risk

Adverse event: anion gap, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (5-15 mmol/L)
Frequency: 2 affected / 5 at risk

Adverse event: alanine aminotransferase (ALT), high
Serious: no
Organ System: Investigations
Notes: above standard reference range (0-40 U/L)
Frequency: 1 affected / 5 at risk

Adverse event: albumin, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (3.5-5.0 g/dL)
Frequency: 1 affected / 5 at risk

Adverse event: alkaline phosphatase, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (0-125 U/L)
Frequency: 1 affected / 5 at risk

Adverse event: calcium, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (8.4-10.5 mg/dL)
Frequency: 1 affected / 5 at risk

Adverse event: total cholesterol, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (0-199 mg/dL); all participants in testosterone enanthate, finasteride group exhibited cholesterol values above standard reference range at baseline (before treatment initiation)
Frequency: 2 affected / 5 at risk

Adverse event: chloride, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (98-108 mmol/L)
Frequency: 1 affected / 5 at risk

Adverse event: CO2, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (23-32 mmol/L)
Frequency: 1 affected / 5 at risk

Adverse event: creatinine, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (0.5-1.2 mg/dL)
Frequency: 2 affected / 5 at risk

Adverse event: C-reactive protein (CRP), high
Serious: no
Organ System: General disorders
Notes: above standard reference range (\<0.1-0.4 mg/dL); 3 of 6 testosterone enanthate, finasteride participants and 1 of 3 placebo participants with elevated CRP exhibited values above standard reference range at baseline (before treatment initiation)
Frequency: 3 affected / 5 at risk

Adverse event: dihydrotestosterone, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (16-79 ng/dL)
Frequency: 1 affected / 5 at risk

Adverse event: dihydrotestosterone, low
Serious: no
Organ System: Investigations
Notes: below standard reference range (16-79 ng/dL)
Frequency: 2 affected / 5 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: impaired ejaculation
Serious: no
Organ System: Reproductive system and breast disorders
Notes: patient reported outcome
Frequency: 1 affected / 5 at risk

Adverse event: estradiol, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (\<=29 pg/mL)
Frequency: 4 affected / 5 at risk

Adverse event: eosinophils, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (0-3%)
Frequency: 5 affected / 5 at risk

Adverse event: erythropoietin, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (2.6-18.5 mIU/mL)
Frequency: 2 affected / 5 at risk

Adverse event: Eye infection
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: falls
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 5 at risk

Adverse event: glucose, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (65-99 mg/dL); 7 of 7 participants in testosterone enanthate, finasteride group and 3 of 5 participants in placebo group exhibited glucose values above standard reference range at baseline (before treatment initiation)
Frequency: 5 affected / 5 at risk

Adverse event: granulocytes, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (54-65%)
Frequency: 4 affected / 5 at risk

Adverse event: granulocytes, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (54-65%)
Frequency: 3 affected / 5 at risk

Adverse event: HDL cholesterol, low
Serious: no
Organ System: Investigations
Notes: below standard reference range (\>=40 mg/dL); 3 of 5 participants in testosterone enanthate, finasteride group and 2 of 2 participants in placebo group with low HDL exhibited values below reference range at baseline (before treatment initiation)
Frequency: 2 affected / 5 at risk

Adverse event: hematocrit, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (41-52%)
Frequency: 1 affected / 5 at risk

Adverse event: hematocrit, low
Serious: no
Organ System: Investigations
Notes: below standard reference range (41-52%)
Frequency: 3 affected / 5 at risk

Adverse event: hemoglobin, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (13.9-18 g/dL)
Frequency: 1 affected / 5 at risk

Adverse event: hemoglobin, low
Serious: no
Organ System: Investigations
Notes: below standard reference range (13.9-18 g/dL)
Frequency: 3 affected / 5 at risk

Adverse event: insulin, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (\<=19.6 uIU/mL)
Frequency: 4 affected / 5 at risk

Adverse event: potassium, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (3.5-5.0 mmol/L)
Frequency: 2 affected / 5 at risk

Adverse event: lymphocytes, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (25-33%)
Frequency: 2 affected / 5 at risk

Adverse event: lymphocytes, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (25-33%)
Frequency: 4 affected / 5 at risk

Adverse event: mean corpuscular hemoglobin concentration, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (31.8-37.1 g/dL)
Frequency: 1 affected / 5 at risk

Adverse event: mean corpuscle volume, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (80-98 um\^3)
Frequency: 1 affected / 5 at risk

Adverse event: monocytes, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (3-7%); 6 of 7 participants in testosterone enanthate, finasteride group and 3 of 5 participants in placebo group exhibited monocyte values above standard reference range at baseline (before treatment initiation)
Frequency: 5 affected / 5 at risk

Adverse event: mean platelet volume, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (7.4-10.5 um\^3)
Frequency: 3 affected / 5 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: self reported
Frequency: 3 affected / 5 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: total protein, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (6.0-8.2 g/dL)
Frequency: 1 affected / 5 at risk

Adverse event: Prostate induration
Serious: no
Organ System: Investigations
Notes: noted on digital rectal exam of prostate
Frequency: 1 affected / 5 at risk

Adverse event: red blood cell count, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (4.44-6.1 M/cmm)
Frequency: 3 affected / 5 at risk

Adverse event: red blood cell distribution width, low
Serious: no
Organ System: General disorders
Notes: below standard reference range (39.0-52.2 fL)
Frequency: 2 affected / 5 at risk

Adverse event: sex-hormone binding globulin (SHBG), high
Serious: no
Organ System: General disorders
Notes: above standard reference range (10-50 nmol/L)
Frequency: 1 affected / 5 at risk

Adverse event: sex-hormone binding globulin (SHBG), low
Serious: no
Organ System: General disorders
Notes: below standard reference range (10-50 nmol/L)
Frequency: 1 affected / 5 at risk

Adverse event: sodium, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (135-145 mmol/L)
Frequency: 1 affected / 5 at risk

Adverse event: testosterone, low
Serious: no
Organ System: Investigations
Notes: below standard reference range (193-836 ng/dL)
Frequency: 1 affected / 5 at risk

Adverse event: triglycerides, high
Serious: no
Organ System: Investigations
Notes: above standard reference range (0-149 mg/dL)
Frequency: 3 affected / 5 at risk

Adverse event: urea nitrogen, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (9-20 mg/dL)
Frequency: 2 affected / 5 at risk

Adverse event: white blood cell count, high
Serious: no
Organ System: General disorders
Notes: above standard reference range (4.6-10.8 k/cmm)
Frequency: 1 affected / 5 at risk