Patient is male
Item
males 30 to 75 years of age
boolean
C0150904 (UMLS CUI [1])
Diabetes Mellitus
Item
type 1 or 2 diabetes and has been treated with at least one anti-hyperglycemic medication and angiotensin-converting enzyme inhibitors (acei)/angiotensin receptor blockers (arb) (renin-angiotensin system [ras] inhibitor) for at least 2 months prior to screening
boolean
C0011849 (UMLS CUI [1,1])
C0877206 (UMLS CUI [1,2])
Estimated glomerular filtration rate
Item
estimated glomerular filtration rate (egfr) equal to or greater than 50 ml/min with the chronic kidney disease epidemiology collaboration (ckd-epi) formula and urine albumin-to-creatinine ratio (uacr) equal to or greater than 30 and less than 5,000 mg/g creatinine.
boolean
C3811844 (UMLS CUI [1])
C0455271 (UMLS CUI [2])
Semen specimen
Item
able to provide a semen specimen at the required intervals.
boolean
C0278355 (UMLS CUI [1])
Baseline sperm concentration
Item
baseline sperm concentration ≥ 30 million per ml.
boolean
C0429845 (UMLS CUI [1])
Hormone suppressive agents
Item
treatment with hormone suppressive agents or cancer chemotherapy within the past 6 months or planned during the study.
boolean
C1535931 (UMLS CUI [1])
C0935451 (UMLS CUI [2])
History of moderate or severe peripheral edema
Item
history of moderate or severe peripheral edema, pulmonary edema or facial edema unrelated to trauma or history of myxedema in the prior 6 months to screening.
boolean
C0085649 (UMLS CUI [1])
C0034063 (UMLS CUI [2])
C0542571 (UMLS CUI [3])
Pulmonary hypertension
Item
history of pulmonary hypertension requiring either oxygen therapy and/or endothelin receptor antagonist or phosphodiesterase therapy or any lung disease requiring oxygen therapy.
boolean
C0020542 (UMLS CUI [1])
Heart failure
Item
documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.
boolean
C0018801 (UMLS CUI [1])
C3898876 (UMLS CUI [2])
Hormone replacement therapy
Item
history of hormone replacement therapy.
boolean
C0282402 (UMLS CUI [1])
Hypogonadism
Item
subject has evidence or history of hypogonadism.
boolean
C0020619 (UMLS CUI [1])