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

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ClinicalTrials.gov Identifier: NCT00104572
Recruitment Status : Completed
First Posted : March 2, 2005
Results First Posted : March 9, 2016
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hypogonadism
Diabetes
Sarcopenia
Osteoporosis
Depression
Interventions Drug: Androgel (Testosterone Gel)
Drug: Anastrozole (Aromatase Inhibitor)
Drug: Placebo tablet
Drug: Placebo gel
Dietary Supplement: Calcium Cardone 500mg with vitamin D 400 IU
Enrollment 44
Recruitment Details  
Pre-assignment Details 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
Hide 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 [1] 13 [1] 9 [2]
Completed 10 10 9
Not Completed 3 3 0
Reason Not Completed
Withdrawal by Subject             3             3             0
[1]
These are the analysed subjects
[2]
(N=11) in placebo, physician removed 2 men due to total testosterone>450 ng/DL, N=9 analysed.
Arm/Group Title Transdermal Testosterone Aromatase Inhibitor Placebo Total
Hide 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 Number of Baseline Participants 13 13 9 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 9 participants 35 participants
72  (5.1) 70  (3.0) 72  (3.4) 71  (1.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 9 participants 35 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
13
 100.0%
13
 100.0%
9
 100.0%
35
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 9 participants 35 participants
13 13 9 35
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 13 participants 13 participants 9 participants 35 participants
137.8  (9.4) 134.5  (14.5) 133.7  (11.2) 135.3  (2.2)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 13 participants 13 participants 9 participants 35 participants
73.3  (5.3) 72.4  (9.4) 73.1  (10.4) 72.9  (0.5)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 13 participants 13 participants 9 participants 35 participants
30.1  (4.0) 27.8  (4.1) 27.6  (3.5) 28.5  (1.4)
Total Testosterone  
Mean (Standard Deviation)
Unit of measure:  ng/dL
Number Analyzed 13 participants 13 participants 9 participants 35 participants
300.1  (81.9) 271.6  (85.6) 303.8  (94.7) 291.8  (17.6)
Bioavailable Testosterone  
Mean (Standard Deviation)
Unit of measure:  ng/dL
Number Analyzed 13 participants 13 participants 9 participants 35 participants
114.4  (37.2) 114.8  (36.3) 91.2  (31.7) 106.8  (13.5)
Estradiol  
Mean (Standard Deviation)
Unit of measure:  ng/dL
Number Analyzed 13 participants 13 participants 9 participants 35 participants
2.0  (0.7) 1.5  (0.6) 1.6  (0.5) 1.700  (0.3)
Sex hormone-binding globulin  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 13 participants 13 participants 9 participants 35 participants
43.4  (22.2) 39.9  (19.4) 58.6  (21.3) 47.30  (10.0)
luteinizing hormone  
Mean (Standard Deviation)
Unit of measure:  mlU/ml
Number Analyzed 13 participants 13 participants 9 participants 35 participants
11.4  (8.2) 6.4  (2.7) 12.2  (10.1) 10.00  (3.1)
follicle-stimulating hormone  
Mean (Standard Deviation)
Unit of measure:  mlU/ml
Number Analyzed 13 participants 13 participants 9 participants 35 participants
8.0  (6.4) 6.5  (5.3) 8.2  (10.9) 7.567  (0.9)
Bone mineral density  
Mean (Standard Deviation)
Unit of measure:  G/cm2
Number Analyzed 13 participants 13 participants 9 participants 35 participants
1.4  (0.2) 1.3  (0.2) 1.2  (0.1) 1.3  (0.1)
lean body mass  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 13 participants 13 participants 9 participants 35 participants
56.0  (12) 54.7  (11.0) 56.0  (7.2) 55.6  (0.8)
Fat mass  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 13 participants 13 participants 9 participants 35 participants
31.6  (10.4) 26.9  (9.6) 28.5  (7.6) 29.0  (2.4)
hand grip  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 13 participants 13 participants 9 participants 35 participants
41.1  (6.9) 39.2  (9.9) 39.3  (7.2) 39.9  (1.1)
knee strength  
Mean (Standard Deviation)
Unit of measure:  Nm
Number Analyzed 13 participants 13 participants 9 participants 35 participants
133.8  (44.3) 138.7  (48.6) 155.4  (41.9) 142.6  (11.3)
1.Primary Outcome
Title Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density
Hide Description bone mineral density lumbar spine for all arms testosterone gel, anastrozole and placebo
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal Testosterone Aromatase Inhibitor Placebo
Hide 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

Overall Number of Participants Analyzed 13 13 9
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description Overnight Growth hormone measures (total hormone secretion) for groups testosterone gel, anastrozole and placebo
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal Testosterone Aromatase Inhibitor Placebo
Hide 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

Overall Number of Participants Analyzed 13 13 9
Mean (Standard Error)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal Testosterone Aromatase Inhibitor Placebo
Hide 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

Overall Number of Participants Analyzed 10 10 9
Mean (Standard Error)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transdermal Testosterone Aromatase Inhibitor Placebo
Hide 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

Overall Number of Participants Analyzed 10 10 9
Mean (Standard Error)
Unit of Measure: cc
4.5  (1.76) -1.66  (3.54) -1.05  (1.52)
Time Frame [Not Specified]
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Transdermal Testosterone Aromatase Inhibitor Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/17 (17.65%)      6/14 (42.86%)      3/13 (23.08%)    
Blood and lymphatic system disorders       
subdural hematoma   0/17 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  1
mildly elevated HCT   1/17 (5.88%)  1 0/14 (0.00%)  0 0/13 (0.00%)  0
Cardiac disorders       
increased heart rate palpitations   0/17 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
General disorders       
dizziness/diarrhea   0/17 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders       
muscle ache  [1]  0/17 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
muscle ache   0/17 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Renal and urinary disorders       
bladder mass  [2]  0/17 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  1
Reproductive system and breast disorders       
elevated PSA   1/17 (5.88%)  1 0/14 (0.00%)  0 0/13 (0.00%)  0
elevated PSA   0/17 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
blood in semen   0/17 (0.00%)  0 1/14 (7.14%)  1 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea on exertion   1/17 (5.88%)  1 0/14 (0.00%)  0 0/13 (0.00%)  0
Vascular disorders       
stent placement   0/17 (0.00%)  0 0/14 (0.00%)  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
[1]
in aromatase group
[2]
bladder mass on transrectal exam
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Transdermal Testosterone Aromatase Inhibitor Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/14 (0.00%)      0/13 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Josephine M. Egan,MD, clinical director NIA
Organization: NIA
Phone: 410-558-8414
EMail: eganj@grc.nia.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT00104572     History of Changes
Other Study ID Numbers: 999904338
04-AG-N338 ( Other Identifier: NIHCC )
First Submitted: March 1, 2005
First Posted: March 2, 2005
Results First Submitted: May 4, 2015
Results First Posted: March 9, 2016
Last Update Posted: November 6, 2018