Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of Testosterone Replacement on Atherosclerosis Progression in Older Men With Low Testosterone Levels
Brief Summary: As men grow older, their testosterone levels decrease with age. One-third of men, 70 years of age or older, have low testosterone levels. It is known that short-term testosterone replacement is safe, and can increase muscle strength and physical function, but the risks of long-term testosterone replacement in older men with low testosterone levels are incompletely understood.

Atherosclerosis is characterized by thickening of the artery walls, and the narrowing of the blood vessels as cholesterol is deposited in the lining of the arteries. It is the major cause of cardiovascular disease including ischemic heart disease (heart attacks) and stroke. Although, historically, there has been a widespread perception that higher levels of testosterone might increase the risk of atherosclerosis, the evidence from research does not support this. In observational studies, higher testosterone levels have been correlated with more favorable cardiovascular risk factors, and supplementation with testosterone to bring older men into the normal range for healthy younger men appears to improve several cardiovascular risk factors, and may slow the progression of atherosclerosis.

The primary purpose of this study is to look at the effects of testosterone replacement on the progression of atherosclerosis in older men. This study is also being done to find out whether replacement with testosterone in older men with low testosterone levels improves their health-related quality of life.


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nebido (testosterone undecanoate) | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Nebido (testosterone undecanoate); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2
B: Arm Label: Testosterone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Testosterone Gel (Androgel) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Testosterone Gel (Androgel); Assigned to Arm(s): Testosterone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Energy Deficit; Type: PLACEBO_COMPARATOR; Interventions: Drug: Sesame Oil | Arm Label: Energy Deficit + Testosterone; Type: EXPERIMENTAL; Interventions: Drug: testosterone enanthate | Intervention Type: DRUG; Name: Sesame Oil; Assigned to Arm(s): Energy Deficit | Intervention Type: DRUG; Name: testosterone enanthate; Assigned to Arm(s): Energy Deficit + Testosterone
D: Arm Label: Active Testosterone Gel; Type: EXPERIMENTAL; Interventions: Drug: Sildenafil citrate (open label), Drug: Testosterone gel | Arm Label: Placebo Gel; Type: PLACEBO_COMPARATOR; Interventions: Drug: Sildenafil citrate (open label), Other: Placebo gel | Intervention Type: DRUG; Name: Sildenafil citrate (open label); Assigned to Arm(s): Active Testosterone Gel, Placebo Gel | Intervention Type: DRUG; Name: Testosterone gel; Assigned to Arm(s): Active Testosterone Gel | Intervention Type: OTHER; Name: Placebo gel; Assigned to Arm(s): Placebo Gel

Answer: B