The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary Artery Disease After Successful Intervention of the Blockage or Narrowed Heart Artery

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT00413244
• Collaborator: Abbott (Industry)
• Enrollment: 51
• Location: 1
• Arms: 2
• Duration (Months): 94
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of the study is to find out if giving the study drug, Androgel (testosterone) as a testosterone replacement help bring the testosterone to an acceptable level and to find out if it will help improve heart condition in males with coronary artery disease (CAD) following successful percutaneous coronary intervention.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: AndroGel 5 Grams; Drug: Placebo	Phase 3

Detailed Description

Males with coronary heart disease have lower serum levels of bioavailable testosterone than men of a similar age with normal coronary angiograms (English, European Heart Journal, 2000). Low plasma testosterone has been associated with known risk factors for CHD, including age, obesity, hyperinsulinemia, diabetes, and adverse lipid profile.

Testosterone has also been shown in numerous studies to be a vasodilator. Recently, testosterone replacement compared with placebo, in hypogonadal men was shown to improve time to ischemic threshold, assessed by treadmill exercise testing at 4 and 12 weeks (Malkin, Heart, 2000). Prior studies had also shown a beneficial effect on exercise-induced ischemia in men with CAD, but not exclusively hypogonadal men (Jaffe,Br Heart J 1977; Rosano, Circulation, 1999; English, Circulation, 2000). In addition, this proposed study would be the first study to assess if the anti-anginal effects persists long term.

This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of testosterone supplementation in hypogonadal men with coronary artery disease following successful revascularization with percutaneous coronary intervention (PCI). Only those men who had successful coronary artery revascularization, and on stable cardiac medical regimen for the prior 4 weeks will be included. Eligible patients will then be randomized on a 2:1 basis with 50 subjects receiving 5 grams of AndroGel and 25 subjects receiving placebo gel.

The men in this study who demonstrate hypogonadism represent a novel population to demonstrate the safety and efficacy of testosterone supplementation to improve cardiac function and outcomes. We hypothesize that treatment of hypogonadism in men with CAD, following successful PCI, will significantly improve cardiac ischemic threshold as assessed by cardiac stress testing. Furthermore, additional cardiac endpoints such as angina status, endothelial function and inflammatory serum markers will also demonstrate significant benefit in the testosterone treated group.

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Cardiac Benefit of Androgen Replacement in Hypogonadal Males With Coronary Artery Disease Following Successful Percutaneous Coronary Intervention (PCI).
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Androgel treatment Androgel 5 grams Androgel treatment - subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months.	Drug: AndroGel 5 Grams; Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo. Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months.
Placebo Comparator: Placebo Placebo - will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months.	Drug: Placebo; Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo. Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months.

Outcome Measures

Primary Outcome Measures

1. Cardiac Stress Test: Time to ST Depression [at 6 months]

   Treadmill exercise testing performed according to the Bruce protocol (MAX-1 Marquette advanced exercise system, software version 002E). The system analyzed the signal averaged ECG and produces a graphical display of the level of the ST segment 80 ms after the J point against time. Time to 1 mm ST depression was measured from computer derived analysis, effectively eliminating observer bias.

2. Cardiac Stress Testing: Exercise Capacity [At 1 month, 3 months, and 6 months]

   Exercise capacity was measured using exercise time.

Secondary Outcome Measures

1. Seattle Angina Questionnaire (SAQ) [up to 6 months]

   A cardiac disease-related quality-of-life measure. The SAQ is a self-report instrument with 19 items that, yields five subscale scores: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important. Data not collected.

2. Reactive Hyperemia Index [6 months]

   The Reactive Hyperemia Index measures the endothelial function and predicts future coronary events. In general RHI values below 2 are categorized as endothelial dysfunction and have a greater plaque burden, whereas higher RHI values are considered normal or improved endothelial function. PAT is the technique to non-invasively assess endothelial function. It comprises finger probes to evaluate digital volume changes.

3. International Prostate Symptom Score (IPSS) [6 months]

   IPSS has 7 questions related to symptoms, each item scored 1-5. Total score can range from 0 to 35 (asymptomatic to very symptomatic). The 8th question refers to the patient's perceived quality of life ranged from 0 to 6 ("delighted" to "terrible".) Data not collected.

4. Metabolic Equivalents of Task (METS) [6 months]

   The Metabolic Equivalent of Task (MET), or simply metabolic equivalent, is a physiological measure expressing the energy cost of physical activities and is defined as the ratio of metabolic rate (and therefore the rate of energy consumption) during a specific physical activity to a reference metabolic rate, set by convention to 3.5 ml O2·kg-1·min-1 or equivalently

5. Aging Male Symptoms (AMS) [At baseline, 1 month, 3 months, and 6 months]

   The scale assesses symptoms of aging and their impact on HRQoL in males, and increases with increasing severity (1 to 5) of subjectively perceived complaints in 17 items. Scale ranges from 17-85 (no symptoms to extremely severe symptoms.)

6. International Index of Erectile Function (IIEF) [At baseline, 1 month, 3 months, and 6 months]

   Questions 1-5 15 of the IIEF relates to erectile function scale 0 - 30 (severe erectile dysfunction to no erectile dysfunction).

7. IIEF-II Orgasmic Function [At baseline, 1 month, 3 months, and 6 months]

   Questions 9-10 of the IIEF relates to orgasmic function scale 0 - 10 (from no impairment to severe impairment)

8. IIEF -III: Sexual Desire [At baseline, 1 month, 3 months, and 6 months]

   Questions 11-12 of the IIEF relates to sexual desire scale 0-10 (from very low to very high)

9. IIEF-IV: Intercourse Satisfaction [At baseline, 1 month, 3 months, and 6 months]

   Questions 6,7, 8 of the IIEF relates to intercourse satisfaction scale 0 - 15 (from very dissatisfied to very satisfied)

10. IIEF-V: Over-all Satisfaction [At baseline, 1 month, 3 months, and 6 months]

    Questions 13,14 of the IIEF relates to specifically to overall satisfaction scale from 0 - 10 (very dissatisfied to very satisfied)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult male patients with coronary artery disease (CAD) (one to three vessel diseased).

• Stable cardiac status at least 3 months after percutaneous coronary intervention (PCI).

• No change in cardiac medications for 4 weeks prior to enrollment.

• Testosterone < 300 ng/dl or free testosterone < 5.0 ng/dl or bioavailable testosterone < 150 ng/dl.

• Sex Hormone Binding Globulin (SHBG) < 7nmol/liter and Free Testosterone < 50pg/dl

• Prostate Specific Antigen (PSA) < 2.5 ng/mL or 2.6-3.7ng/mL with a negative prostate biopsy within the last 6 months and pathology report available for investigator's review.

• Subgroup of diabetics with well to moderately controlled diabetes (defined by a HgbA1c of < 9mg/dL.

Exclusion Criteria:

• Hematocrit greater than 50%.

• Severe hypertension (exhibit systolic blood pressure >180mmHg and diastolic blood pressure >110 mmHg at baseline visit or a have a history of malignant hypertension.

• Significant cardiac arrhythmia (supraventricular tachycardia [SVT] or ventricular tachycardia with heart rate exceeding 110 beats per minute at Visit 1).

• ECG abnormalities precluding ST segment analysis on treadmill, or inability to walk on treadmill.

• Poorly controlled, symptomatic, active medical problems (HIV, hepatitis, cancer, benign prostatic hypertrophy, alcohol or drug abuse, major depressive disorder).

• Neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol.

• History of prostate cancer

• History of hypersensitivity to transdermal testosterone gel.

• International Prostate Symptom Score (IPSS) >19 at Visit 1.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai
• Abbott

Investigators

• Principal Investigator: Mary Ann McLaughlin, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT00413244
• Other Study ID Numbers: GCO 06-1081
• First Posted: Dec 19, 2006
• Last Update Posted: Jan 5, 2017
• Last Verified: Nov 1, 2016

• Keywords provided by Icahn School of Medicine at Mount Sinai: Hypogonadal; coronary artery disease; percutaneous coronary intervention (PCI)
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Testosterone

Study Results

Participant Flow

Recruitment Details	Subjects recruited for the study were male patients with stable cardiac status at least 3 months after Percutaneous Coronary Intervention (PCI) at the Cardiac Catheterization Lab of Mount Sinai Hospital from July 2007 to August 2013.

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Period Title: Overall Study
STARTED	31	20
COMPLETED	21	19
NOT COMPLETED	10	1

Baseline Characteristics

Arm/Group Title	Androgel	Placebo	Total
Arm/Group Description	Androgel 5 grams	Matching Placebo	Total of all reporting groups
Overall Participants	31	20	51
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.3 (8.2)	58.9 (7.3)	58.5 (7.81)
Gender (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	31 100%	20 100%	51 100%
Hypertension (participants) [Number]
Yes	30 96.8%	16 80%	46 90.2%
No	1 3.2%	4 20%	5 9.8%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.8 (5.8)	28.0 (4.3)	29.7 (5.4)
Diabetes (participants) [Number]
Yes	16 51.6%	6 30%	22 43.1%
No	15 48.4%	14 70%	29 56.9%
Total Testosterone (ng/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/dL]	246.7 (63.5)	263.7 (71.9)	253.36 (66.8)
Systolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	123.81 (13.81)	128.05 (20.84)	125.47 (16.85)
Diastolic Blood Pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	76.32 (9.03)	75.10 (11.65)	75.84 (10.04)
Hematocrit (percent of cells) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent of cells]	40.69 (3.00)	40.93 (3.18)	40.78 (3.04)
White Blood Cell Count (cells x10^3/uL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells x10^3/uL]	6.25 (1.78)	6.49 (1.63)	6.34 (1.71)
Red Blood Cell Count (cells x10^6/uL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells x10^6/uL]	4.58 (0.44)	4.67 (0.42)	4.62 (0.43)
Aging male syndrome questionnaire (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	36.48 (11.36)	35.85 (10.24)	36.24 (10.83)
Exercise Time (seconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [seconds]	507.29 (153.48)	530.00 (120.08)	516.20 (104.49)
International Prostate Symptom Score (IPSS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.68 (4.77)	4.55 (4.7)	5.24 (4.73)
Metabolic equivalent of task (METs) (MET units) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [MET units]	10.03 (2.58)	10.05 (1.99)	10.04 (2.34)
Reactive hyperemia index (RHI) (ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml]	1.97 (0.72)	1.85 (0.54)	1.92 (0.66)
Total Cholesterol (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	157.29 (47.10)	144.45 (28.85)	152.25 (41.08)
LDL (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	86.48 (40.52)	80.90 (26.77)	84.29 (35.57)
Triglycerides (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	142.23 (100.95)	109.90 (50.86)	129.55 (85.74)
Waist Circumference (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	42.66 (5.21)	41.31 (4.65)	42.13 (4.99)
Weight (lbs) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lbs]	205.73 (39.22)	194.50 (36.62)	201.32 (38.25)

Outcome Measures

1. Primary Outcome

Title	Cardiac Stress Test: Time to ST Depression
Description	Treadmill exercise testing performed according to the Bruce protocol (MAX-1 Marquette advanced exercise system, software version 002E). The system analyzed the signal averaged ECG and produces a graphical display of the level of the ST segment 80 ms after the J point against time. Time to 1 mm ST depression was measured from computer derived analysis, effectively eliminating observer bias.
Time Frame	at 6 months

Outcome Measure Data

Analysis Population Description

Subjects analyzed were only those subjects with ST depression at baseline

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Measure Participants	10	11
at 1 month	439.1 (205.2)	279.5 (130.0)
at 3 months	364.0 (141.4)	292.6 (63.5)
at 6 months	433.0 (123.2)	342.2 (62.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Androgel, Placebo
	Comments	Statistician used all the time points post-baseline together ("Overall"). The result gives the estimates and 95% CI of the treatment effect from longitudinal analyses (generalized estimating equation method) which basically pools data from all visits post-baseline.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	log mean
	Comments

2. Primary Outcome

Title	Cardiac Stress Testing: Exercise Capacity
Description	Exercise capacity was measured using exercise time.
Time Frame	At 1 month, 3 months, and 6 months

Outcome Measure Data

Analysis Population Description

Subjects analyzed were only those subjects with ST depression at baseline

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Measure Participants	10	11
at 1 month	589.7 (114.6)	452.4 (122.7)
at 3 months	607.6 (152.0)	472.1 (98.6)
at 6 months	614.0 (115.4)	470.0 (143.8)

3. Secondary Outcome

Title	Seattle Angina Questionnaire (SAQ)
Description	A cardiac disease-related quality-of-life measure. The SAQ is a self-report instrument with 19 items that, yields five subscale scores: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life. A change of 10 points in any of the subscales is considered to be clinically important. Data not collected.
Time Frame	up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Measure Participants	0	0

4. Secondary Outcome

Title	Reactive Hyperemia Index
Description	The Reactive Hyperemia Index measures the endothelial function and predicts future coronary events. In general RHI values below 2 are categorized as endothelial dysfunction and have a greater plaque burden, whereas higher RHI values are considered normal or improved endothelial function. PAT is the technique to non-invasively assess endothelial function. It comprises finger probes to evaluate digital volume changes.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Subjects analyzed were only those subjects with ST depression at baseline

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Measure Participants	10	11
At baseline	1.96 (0.72)	1.85 (0.54)
at 1 month	1.85 (0.49)	1.81 (0.52)
at 3 months	1.70 (0.49)	1.77 (0.37)
at 6 moths	1.83 (0.58)	1.74 (0.53)

5. Secondary Outcome

Title	International Prostate Symptom Score (IPSS)
Description	IPSS has 7 questions related to symptoms, each item scored 1-5. Total score can range from 0 to 35 (asymptomatic to very symptomatic). The 8th question refers to the patient's perceived quality of life ranged from 0 to 6 ("delighted" to "terrible".) Data not collected.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Measure Participants	0	0

6. Secondary Outcome

Title	Metabolic Equivalents of Task (METS)
Description	The Metabolic Equivalent of Task (MET), or simply metabolic equivalent, is a physiological measure expressing the energy cost of physical activities and is defined as the ratio of metabolic rate (and therefore the rate of energy consumption) during a specific physical activity to a reference metabolic rate, set by convention to 3.5 ml O2·kg-1·min-1 or equivalently
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Subjects analyzed were only those subjects with ST depression at baseline

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Measure Participants	10	11
at baseline	11.0 (2.2)	9.0 (1.3)
at 1 month	11.4 (2.2)	9.0 (1.9)
at 3 months	11.9 (3.0)	9.2 (1.5)
at 6 months	12.2 (2.2)	9.4 (2.3)

7. Secondary Outcome

Title	Aging Male Symptoms (AMS)
Description	The scale assesses symptoms of aging and their impact on HRQoL in males, and increases with increasing severity (1 to 5) of subjectively perceived complaints in 17 items. Scale ranges from 17-85 (no symptoms to extremely severe symptoms.)
Time Frame	At baseline, 1 month, 3 months, and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Measure Participants	31	20
Baseline	36.5 (11.4)	35.8 (10.2)
At 1 month	32.9 (10.1)	29.8 (11.6)
At 3 months	36.5 (11.4)	35.9 (10.2)
At 6 months	31.2 (8.5)	31.4 (9.8)

8. Secondary Outcome

Title	International Index of Erectile Function (IIEF)
Description	Questions 1-5 15 of the IIEF relates to erectile function scale 0 - 30 (severe erectile dysfunction to no erectile dysfunction).
Time Frame	At baseline, 1 month, 3 months, and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Measure Participants	31	20
at baseline	12.4 (8.7)	12.2 (9.4)
at 1 month	14.1 (9.0)	10.1 (9.2)
at 3 months	15.7 (9.6)	14.2 (10.8)
at 6 months	15.0 (10.0)	12.5 (9.7)

9. Secondary Outcome

Title	IIEF-II Orgasmic Function
Description	Questions 9-10 of the IIEF relates to orgasmic function scale 0 - 10 (from no impairment to severe impairment)
Time Frame	At baseline, 1 month, 3 months, and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Measure Participants	31	20
at baseline	4.8 (3.3)	4.4 (3.6)
at 1 month	5.9 (3.5)	4.2 (4.2)
at 3 months	5.7 (3.7)	5.8 (4.2)
at 6 months	6.1 (3.4)	5.5 (4.3)

10. Secondary Outcome

Title	IIEF -III: Sexual Desire
Description	Questions 11-12 of the IIEF relates to sexual desire scale 0-10 (from very low to very high)
Time Frame	At baseline, 1 month, 3 months, and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Measure Participants	31	20
at baseline	5.0 (2.1)	5.4 (1.8)
at 1 month	5.6 (2.7)	4.8 (2.4)
at 3 months	6.3 (2.3)	5.6 (2.0)
at 6 months	6.6 (2.4)	5.5 (2.6)

11. Secondary Outcome

Title	IIEF-IV: Intercourse Satisfaction
Description	Questions 6,7, 8 of the IIEF relates to intercourse satisfaction scale 0 - 15 (from very dissatisfied to very satisfied)
Time Frame	At baseline, 1 month, 3 months, and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Measure Participants	31	20
at baseline	5.5 (4.0)	5.0 (4.6)
at 1 month	6.2 (4.6)	3.6 (4.4)
at 3 months	6.8 (4.9)	6.0 (5.1)
at 6 months	6.9 (5.1)	5.2 (5.1)

12. Secondary Outcome

Title	IIEF-V: Over-all Satisfaction
Description	Questions 13,14 of the IIEF relates to specifically to overall satisfaction scale from 0 - 10 (very dissatisfied to very satisfied)
Time Frame	At baseline, 1 month, 3 months, and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Androgel	Placebo
Arm/Group Description	Androgel 5 grams	Matching Placebo
Measure Participants	31	20
at baseline	4.8 (2.5)	4.3 (2.4)
at 1 month	4.9 (2.9)	3.8 (2.7)
at 3 months	5.2 (2.9)	5.2 (3.0)
at 6 months	6.0 (3.0)	4.9 (3.2)

Adverse Events

Time Frame	6 months
Arm/Group Title	Androgel		Placebo
Arm/Group Description	Androgel 5 grams		Matching Placebo
All Cause Mortality
	Androgel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Androgel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Androgel		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.