Effects of Aromatase Inhibition Versus Testosterone in Older Men With Low Testosterone: Randomized-Controlled Trial.

• Sponsor: National Institute on Aging (NIA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00104572
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 3
• Duration (Months): 130
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Background: Men≥65 years often produce lower levels of testosterone, meaning there is less testosterone circulating to the tissues of the body. This is associated with negative effects on muscle strength, bone density, sexual function, mood, and the ability to think to the best of one's ability. Testosterone replacement therapy often involves injections, patches, or gels that help to raise circulating testosterone levels, but these therapies often have side effects because they lead to imbalance of other hormones. Researchers have been studying the effectiveness of anastrozole, a drug that can lower estrogen levels while simultaneously increasing testosterone levels, as a treatment for the negative effects of decreased circulating testosterone levels that occur naturally with aging. Objectives: To evaluate whether anastrozole is as effective as testosterone gel in improving bone and muscle strength, hormone levels, and brain function in men over 65 years of age. Eligibility: Healthy men at least 65 years of age who have low levels of testosterone. Design: The study involves six study visits over a total of 12 months: screening, baseline, 6 weeks, 3 months, 6 months, and 12 months. All participants will receive calcium and vitamin D supplements to take daily, and will be randomized to one of three groups:Testosterone gel and placebo tablet, Anastrozole tablet and placebo gel, Placebo tablet and gel. Participants will have the following tests at each specified visit:Screening: Blood tests and rectal ultrasound to evaluate the prostate;Baseline: Blood and urine tests; growth hormone levels, muscle strength, bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six weeks: Blood tests and dose adjustment of the gel or tablet;Three months: Blood and urine tests; growth hormone, muscle strength, bone density, and balance evaluation; and questionnaires on quality of life, sexual function, depression, and urinary symptoms;Six months: Blood and urine tests; muscle strength, bone density, and balance evaluation; cognitive testing; and questionnaires on quality of life, sexual function, depression, and urinary symptoms;Twelve months: Blood and urine tests; rectal ultrasound; muscle strength, bone density, and balance evaluation; imaging studies; cognitive testing; and questionnaires on quality of life, sexual function, depression, and urinary symptoms.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism; Diabetes; Sarcopenia; Osteoporosis; Depression	Drug: Androgel (Testosterone Gel); Drug: Anastrozole (Aromatase Inhibitor); Drug: Placebo tablet; Drug: Placebo gel; Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU	Phase 2

Detailed Description

Approximately 20% of men over the age of 70 have low testosterone levels. In some studies, testosterone replacement has resulted in improvement in bone mass, muscle strength, quality of life and memory function. In the body, testosterone is converted into estrogen. Hence, it is unclear whether these beneficial effects are due to testosterone or estrogen. Research has shown that inhibition of estrogen production in men results in an increase in testosterone levels.

In this study, patients will be assigned to one of three groups: one group will receive testosterone gel and a placebo tablet, one group will receive a 1mg Anastrozole tablet and a placebo gel, and one group will receive a placebo tablet and placebo gel. Each group will receive a daily dose of calcium with vitamin D. The study requires 6 visits over a 12-month period for testing and evaluation. Two of the 6 visits will require an overnight stay in the hospital so that an intravenous (IV) line can be placed in the arm to allow samples to be drawn throughout the night. Testing will include a cardiac stress test, a glucose tolerance test, bone and muscle tests, evaluation of memory function, etc. For the safety of the prostate, we will perform a prostate ultrasound at the start and end of the study and we will monitor urinary symptoms, prostate specific antigen (PSA) levels and the prostate exam throughout the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effects of Aromatase Inhibition and Testosterone Replacement in Sex Steroids, Pituitary Hormones, Markers of Bone Turnover, Muscle Strength, and Cognition in Older Men
• Study Start Date: Mar 1, 2004
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: (Androgel) testosterone gel 17 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months and 'Calcium Cardone 500mg with vitamin D 400 IU'	Drug: Androgel (Testosterone Gel); 1 mg tablet for 12 months; Drug: Placebo tablet; Daily for 12 months; Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU; 1 tablet three times a day
Experimental: anastrozole (Aromatase inhibitor) 14 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months and 'Calcium Cardone 500mg with vitamin D 400 IU'	Drug: Anastrozole (Aromatase Inhibitor); Drug: Placebo gel; Daily for 12 months; Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU; 1 tablet three times a day
Placebo Comparator: placebo 13 participants will receive a placebo tablet and placebo gel daily for 12 months and 'Calcium Cardone 500mg with vitamin D 400 IU'	Drug: Placebo tablet; Daily for 12 months; Drug: Placebo gel; Daily for 12 months; Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU; 1 tablet three times a day

Outcome Measures

Primary Outcome Measures

1. Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density [1 year]

   bone mineral density lumbar spine for all arms testosterone gel, anastrozole and placebo

Secondary Outcome Measures

1. Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release [1 year]

   Overnight Growth hormone measures (total hormone secretion) for groups testosterone gel, anastrozole and placebo

2. Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism [1 year]

   Primary outcome HOMA-IR for all groups testosterone gel, anastrozole and placebo Insulin resistance measure by HOMA-IR is a score if a person is insulin resistance the score should be between minimum 0.7- maximum 2 or more. Absolute changes in HOMAIR in all treatment arms, calculation time frame 1 year minus baseline point.

3. Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function [1 year]

   rectal ultrasound prostate volume for all groups testosterone gel, anastrozole and placebo. Absolute changes in prostate volume in all treatment arms, calculation time frame 1 year minus baseline point.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

• INCLUSION CRITERIA:

1. Men age 65 years or older

2. Serum testosterone level less than or equal to 350 ng/dl

3. Subject is able to complete an informed consent

EXCLUSION CRITERIA:

1. History of Stroke

2. History of Dementia

3. History of Diabetes

4. Blood pressure at rest of > 155/90 mmHg. Elevated systolic or diastolic reading renders subject ineligible

5. Chronic medical condition, i.e. congestive heart failure

6. Arthritis, severe enough to prevent completion of the strength testing, history of joint replacement of knees or hip.

7. Inability to walk 50 meters

8. Known disease of the bone and/or taking medications to treat osteoporosis, i.e.

Fosamax, Evista, Miacalcin

1. History of Gastric surgery

2. History of prostate cancer or any other cancers, including blood dyscrasias

3. History of severe benign prostatic hyperplasia (causing urinary problems)

4. History of heart attack or open-heart surgery within the past 6 months

5. Use of steroids within the past 3 months, including prednisone and/or cortisone injections, and inhaled steroids. Topical steroid cream is acceptable.

6. If you do not agree to refrain from taking the drugs Viagra, Cialis or Levitra for the duration of the study

7. Use of anabolic steroids, i.e. testosterone, (or any analog of testosterone) Dehydroepiandrosterone or any growth promoters i.e. growth hormone itself or analogs of growth hormone

8. Use of anti-androgen medications, i.e. Aldactone, Tagamet, Proscar, estrogens

9. Use of Dilantin or Phenobarbital

10. Alcohol intake > 30 grams (drink more than 2 beers per day OR more than 1 glass of wine or cocktail daily)

11. Currently smokes any tobacco product

12. Having started a new medication during the past three months which may interfere with the outcome measures of the study

13. Polycythemia

14. Prostate specific antigen > 4.0 ng/dl

15. Hematocrit < 36

16. Liver function tests greater than 2 times upper normal limits or abnormal electrolytes, calcium or Parathyroid hormone , at the discretion of the investigator

17. Mini Mental Status Exam score less than or equal to 24

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Aging, Clinical Research Unit	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Josephine M Egan, M.D., National Institute on Aging (NIA)

Study Documents (Full-Text)

None provided.

More Information

Publications

• Gray A, Feldman HA, McKinlay JB, Longcope C. Age, disease, and changing sex hormone levels in middle-aged men: results of the Massachusetts Male Aging Study. J Clin Endocrinol Metab. 1991 Nov;73(5):1016-25.
• Jeffcoate SL, Brooks RV, Lim NY, London DR, Prunty FT, Spathis GS. Androgen production in hypogonadal men. J Endocrinol. 1967 Apr;37(4):401-11.
• Wheeler MJ. The determination of bio-available testosterone. Ann Clin Biochem. 1995 Jul;32 ( Pt 4):345-57. Review.

• Responsible Party: National Institute on Aging (NIA)
• ClinicalTrials.gov Identifier: NCT00104572
• Other Study ID Numbers: 999904338; 04-AG-N338
• First Posted: Mar 2, 2005
• Last Update Posted: Nov 6, 2018
• Last Verified: Mar 1, 2016

• Keywords provided by National Institute on Aging (NIA): Estrogen; Glucose Tolerance; Bone Density; Quality-of-Life; Sarcopenia
• Additional relevant MeSH terms: Osteoporosis; Sarcopenia; Hypogonadism; Vitamin D; Anastrozole; Calcium; Testosterone; Aromatase Inhibitors

Study Results

Participant Flow

Pre-assignment Detail	The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.

Arm/Group Title	Transdermal Testosterone	Aromatase Inhibitor	Placebo
Arm/Group Description	13 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months Androgel (Testosterone Gel): 1 mg tablet for 12 months Placebo tablet: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	13 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months Anastrozole (Aromatase Inhibitor) Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	9 participants will receive a placebo tablet and placebo gel daily for 12 months Placebo tablet: Daily for 12 months Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
Period Title: Overall Study
STARTED	13	13	9
COMPLETED	10	10	9
NOT COMPLETED	3	3	0

Baseline Characteristics

Arm/Group Title	Transdermal Testosterone	Aromatase Inhibitor	Placebo	Total
Arm/Group Description	participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months Androgel (Testosterone Gel): 1 mg tablet for 12 months Placebo tablet: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months Anastrozole (Aromatase Inhibitor) Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	participants will receive a placebo tablet and placebo gel daily for 12 months Placebo tablet: Daily for 12 months Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	Total of all reporting groups
Overall Participants	13	13	9	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72 (5.1)	70 (3.0)	72 (3.4)	71 (1.2)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%
Male	13 100%	13 100%	9 100%	35 100%
Region of Enrollment (participants) [Number]
United States	13 100%	13 100%	9 100%	35 100%
Systolic blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	137.8 (9.4)	134.5 (14.5)	133.7 (11.2)	135.3 (2.2)
Diastolic blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	73.3 (5.3)	72.4 (9.4)	73.1 (10.4)	72.9 (0.5)
Body mass index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	30.1 (4.0)	27.8 (4.1)	27.6 (3.5)	28.5 (1.4)
Total Testosterone (ng/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/dL]	300.1 (81.9)	271.6 (85.6)	303.8 (94.7)	291.8 (17.6)
Bioavailable Testosterone (ng/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/dL]	114.4 (37.2)	114.8 (36.3)	91.2 (31.7)	106.8 (13.5)
Estradiol (ng/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ng/dL]	2.0 (0.7)	1.5 (0.6)	1.6 (0.5)	1.700 (0.3)
Sex hormone-binding globulin (nmol/L) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [nmol/L]	43.4 (22.2)	39.9 (19.4)	58.6 (21.3)	47.30 (10.0)
luteinizing hormone (mlU/ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mlU/ml]	11.4 (8.2)	6.4 (2.7)	12.2 (10.1)	10.00 (3.1)
follicle-stimulating hormone (mlU/ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mlU/ml]	8.0 (6.4)	6.5 (5.3)	8.2 (10.9)	7.567 (0.9)
Bone mineral density (g/cm2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g/cm2]	1.4 (0.2)	1.3 (0.2)	1.2 (0.1)	1.3 (0.1)
lean body mass (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	56.0 (12)	54.7 (11.0)	56.0 (7.2)	55.6 (0.8)
Fat mass (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	31.6 (10.4)	26.9 (9.6)	28.5 (7.6)	29.0 (2.4)
hand grip (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	41.1 (6.9)	39.2 (9.9)	39.3 (7.2)	39.9 (1.1)
knee strength (Nm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Nm]	133.8 (44.3)	138.7 (48.6)	155.4 (41.9)	142.6 (11.3)

Outcome Measures

1. Primary Outcome

Title	Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density
Description	bone mineral density lumbar spine for all arms testosterone gel, anastrozole and placebo
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transdermal Testosterone	Aromatase Inhibitor	Placebo
Arm/Group Description	participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months Androgel (Testosterone Gel): 1 mg tablet for 12 months Placebo tablet: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months Anastrozole (Aromatase Inhibitor) Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	participants will receive a placebo tablet and placebo gel daily for 12 months Placebo tablet: Daily for 12 months Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
Measure Participants	13	13	9
Mean (Standard Deviation) [g/cm2]	0.042 (0.008)	0.008 (0.012)	0.047 (0.013)

2. Secondary Outcome

Title	Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release
Description	Overnight Growth hormone measures (total hormone secretion) for groups testosterone gel, anastrozole and placebo
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transdermal Testosterone	Aromatase Inhibitor	Placebo
Arm/Group Description	participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months Androgel (Testosterone Gel): 1 mg tablet for 12 months Placebo tablet: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months Anastrozole (Aromatase Inhibitor) Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	participants will receive a placebo tablet and placebo gel daily for 12 months Placebo tablet: Daily for 12 months Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
Measure Participants	13	13	9
Mean (Standard Error) [ng/ml/8h]	5.8 (1.4)	10 (2.2)	7.7 (2.2)

3. Secondary Outcome

Title	Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism
Description	Primary outcome HOMA-IR for all groups testosterone gel, anastrozole and placebo Insulin resistance measure by HOMA-IR is a score if a person is insulin resistance the score should be between minimum 0.7- maximum 2 or more. Absolute changes in HOMAIR in all treatment arms, calculation time frame 1 year minus baseline point.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transdermal Testosterone	Aromatase Inhibitor	Placebo
Arm/Group Description	participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months Androgel (Testosterone Gel): 1 mg tablet for 12 months Placebo tablet: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months Anastrozole (Aromatase Inhibitor) Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	participants will receive a placebo tablet and placebo gel daily for 12 months Placebo tablet: Daily for 12 months Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
Measure Participants	10	10	9
Mean (Standard Error) [score on a scale]	-0.05 (0.21)	0.15 (0.10)	-0.11 (0.26)

4. Secondary Outcome

Title	Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function
Description	rectal ultrasound prostate volume for all groups testosterone gel, anastrozole and placebo. Absolute changes in prostate volume in all treatment arms, calculation time frame 1 year minus baseline point.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transdermal Testosterone	Aromatase Inhibitor	Placebo
Arm/Group Description	participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months Androgel (Testosterone Gel): 1 mg tablet for 12 months Placebo tablet: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months Anastrozole (Aromatase Inhibitor) Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day	participants will receive a placebo tablet and placebo gel daily for 12 months Placebo tablet: Daily for 12 months Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
Measure Participants	10	10	9
Mean (Standard Error) [cc]	4.5 (1.76)	-1.66 (3.54)	-1.05 (1.52)

Adverse Events

Adverse Event Reporting Description	The study randomized 44 subjects, however 9 of them stop the study before having the second visit completed, so we started the analysis with 35 subjects. The participant flow module has 35 subjects, because these subjects have a baseline and 3 months endpoints.
Arm/Group Title	Transdermal Testosterone		Aromatase Inhibitor		Placebo
Arm/Group Description	participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months Androgel (Testosterone Gel): 1 mg tablet for 12 months Placebo tablet: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day		participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months Anastrozole (Aromatase Inhibitor) Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day		participants will receive a placebo tablet and placebo gel daily for 12 months Placebo tablet: Daily for 12 months Placebo gel: Daily for 12 months Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day
All Cause Mortality
	Transdermal Testosterone		Aromatase Inhibitor		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Transdermal Testosterone		Aromatase Inhibitor		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/17 (17.6%)		6/14 (42.9%)		3/13 (23.1%)
Blood and lymphatic system disorders
subdural hematoma	0/17 (0%)	0	0/14 (0%)	0	1/13 (7.7%)	1
mildly elevated HCT	1/17 (5.9%)	1	0/14 (0%)	0	0/13 (0%)	0
Cardiac disorders
increased heart rate palpitations	0/17 (0%)	0	1/14 (7.1%)	1	0/13 (0%)	0
General disorders
dizziness/diarrhea	0/17 (0%)	0	1/14 (7.1%)	1	0/13 (0%)	0
Musculoskeletal and connective tissue disorders
muscle ache	0/17 (0%)	0	1/14 (7.1%)	1	0/13 (0%)	0
muscle ache	0/17 (0%)	0	1/14 (7.1%)	1	0/13 (0%)	0
Renal and urinary disorders
bladder mass	0/17 (0%)	0	0/14 (0%)	0	1/13 (7.7%)	1
Reproductive system and breast disorders
elevated PSA	1/17 (5.9%)	1	0/14 (0%)	0	0/13 (0%)	0
elevated PSA	0/17 (0%)	0	1/14 (7.1%)	1	0/13 (0%)	0
blood in semen	0/17 (0%)	0	1/14 (7.1%)	1	0/13 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea on exertion	1/17 (5.9%)	1	0/14 (0%)	0	0/13 (0%)	0
Vascular disorders
stent placement	0/17 (0%)	0	0/14 (0%)	0	1/13 (7.7%)	1
Other (Not Including Serious) Adverse Events
	Transdermal Testosterone		Aromatase Inhibitor		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/14 (0%)		0/13 (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.