Participants with congenital or acquired hypogonadism for whom long-term therapy with placebo would not be medically appropriate
Participants with prostate specific antigen (PSA) > 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
Participants who have been treated with testosterone in the past 6 months and for whom testosterone therapy is contraindicated
Confirmed testosterone < 100 ng/dL
Body Mass Index (BMI) > 50
Hemoglobin A1c (HbA1C) > 11%
Hematocrit (Hct) > 50%
Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min
History of deep vein thrombosis or pulmonary embolism or prostate cancer or heart failure (Class III and IV).

NCT03518034_exc_T1
Condition
acquired hypogonadism
NCT03518034_exc_T2
Condition
congenital hypogonadism
NCT03518034_exc_T4
Measurement
prostate specific antigen (PSA)
NCT03518034_exc_T5
Value
> 3.0 ng/mL
NCT03518034_exc_T6
Drug
5-alpha reductase inhibitors
NCT03518034_exc_T7
Value
1.5
NCT03518034_exc_T8
Scope
> 3.0 ng/mL (or 1.5 if on 5-alpha reductase inhibitors)
NCT03518034_exc_T9
Drug
testosterone
NCT03518034_exc_T10
Temporal
in the past 6 months
NCT03518034_exc_T11
Condition
contraindicated
NCT03518034_exc_T12
Procedure
testosterone therapy
NCT03518034_exc_T13
Drug
testosterone
NCT03518034_exc_T14
Measurement
Confirmed testosterone
NCT03518034_exc_T15
Value
< 100 ng/dL
NCT03518034_exc_T16
Measurement
Body Mass Index (BMI)
NCT03518034_exc_T17
Value
> 50
NCT03518034_exc_T18
Measurement
Hemoglobin A1c (HbA1C)
NCT03518034_exc_T19
Value
> 11%
NCT03518034_exc_T20
Measurement
Hematocrit (Hct)
NCT03518034_exc_T21
Value
> 50%
NCT03518034_exc_T22
Measurement
Estimated Glomerular Filtration Rate (eGFR)
NCT03518034_exc_T23
Value
< 30 ml/min
NCT03518034_exc_T24
Condition
deep vein thrombosis
NCT03518034_exc_T25
Condition
pulmonary embolism
NCT03518034_exc_T26
Condition
prostate cancer
NCT03518034_exc_T27
Condition
heart failure
NCT03518034_exc_T28
Qualifier
Class III
NCT03518034_exc_T29
Qualifier
I and
NCT03518034_exc_T30
Scope
Class III and IV