Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized, Placebo-controlled, Double-blind Study of Seven Coordinated Testosterone Treatment Trials in Older Men
Brief Summary: The Testosterone Trials are a multi-center set of trials involving 12 clinical sites geographically distributed across the United States.

The primary specific aims are to test the hypotheses that testosterone treatment of elderly men whose serum testosterone concentrations are unequivocally low - and who have symptoms and objectively measured abnormalities in at least one of five areas that could be due to low testosterone (physical or sexual function, vitality, cognition, and anemia) - will result in more favorable changes in those abnormalities than placebo treatment.

Two additional trials have been incorporated into the T Trial. Only men enrolled in the T Trial are eligible to participate in these trials.

* The Cardiovascular Trial will examine if testosterone treatment results in more favorable changes in cardiovascular risk factors, compared to placebo.
* The Bone Trial will test the hypothesis that testosterone treatment will increase volumetric trabecular bone mineral density (vBMD) of the lumbar spine as measured by quantitative computed tomography (QCT), compared with placebo treatment.

A Pharmacokinetic (PK) Study is also being conducted within the context of the interventional T Trial. It will examine the variability of the serum testosterone (T) concentration after application of testosterone gel or placebo, four months after the start of treatment.


Options:
A: Arm Label: Oral testosterone undecanoate (TU); Type: EXPERIMENTAL; Interventions: Drug: Oral testosterone undecanoate | Arm Label: topical testosterone gel; Type: ACTIVE_COMPARATOR; Interventions: Drug: topical testosterone gel | Intervention Type: DRUG; Name: Oral testosterone undecanoate; Assigned to Arm(s): Oral testosterone undecanoate (TU) | Intervention Type: DRUG; Name: topical testosterone gel; Assigned to Arm(s): topical testosterone gel
B: Arm Label: AndroGel 1.62%; Type: ACTIVE_COMPARATOR; Interventions: Drug: AndroGel® | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: AndroGel®; Assigned to Arm(s): AndroGel 1.62% | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Testosterone plus Lifestyle Therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Testosterone, Other: Lifestyle Therapy | Arm Label: Placebo plus Lifestyle Therapy; Type: PLACEBO_COMPARATOR; Interventions: Other: Lifestyle Therapy, Drug: Placebo | Intervention Type: DRUG; Name: Testosterone; Assigned to Arm(s): Testosterone plus Lifestyle Therapy | Intervention Type: OTHER; Name: Lifestyle Therapy; Assigned to Arm(s): Placebo plus Lifestyle Therapy, Testosterone plus Lifestyle Therapy | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo plus Lifestyle Therapy
D: Arm Label: AndroGel® (testosterone gel); Type: ACTIVE_COMPARATOR; Interventions: Drug: AndroGel® (testosterone gel) | Arm Label: Placebo gel; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: AndroGel® (testosterone gel); Assigned to Arm(s): AndroGel® (testosterone gel) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo gel

Answer: D